CTRI/2024/04/066196 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On:
30/01/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study of Propiomazine Tablets 25 mg in healthy, adult, human Subjects under fasting conditions.
Scientific Title of Study
An open-label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover bioequivalence study of Propiomazine Tablets 25 mg [Test] of Centaur Pharmaceuticals Pvt. Ltd. India with Propavan® 25 mg (Propiomazine Tablets 25 mg) [Reference] of Sanofi-aventis AB, Stockholm, Sweden, in healthy, adult, human Subjects under fasting conditions.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
LBS-054-23/1, version no. 01 dated 12-Dec-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mukund Zarapkar
Designation
Vice President- Clinical
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Address
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400055 India
Phone
912266499154
Fax
912266499239
Email
drzarapkar@lifesan.in
Details of Contact Person Scientific Query
Name
Dr Mukund Zarapkar
Designation
Vice President- Clinical
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Address
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India.
MAHARASHTRA 400055 India
Phone
912266499154
Fax
912266499239
Email
drzarapkar@lifesan.in
Details of Contact Person Public Query
Name
Dr Mukund Zarapkar
Designation
Vice President- Clinical
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Address
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India.
MAHARASHTRA 400055 India
Phone
912266499154
Fax
912266499239
Email
drzarapkar@lifesan.in
Source of Monetary or Material Support
Sponsor of the study i.e. Centaur Pharmaceuticals Pvt. Ltd., India
Primary Sponsor
Name
Centaur Pharmaceuticals Pvt. Ltd
Address
Centaur House, Opp. Grand Hyatt, Vakola, Santacruz – East, Mumbai - 400055, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
CRO LifeSan Clinical Research division of Centaur Pharmaceuticals Pvt Ltd
5th and 6th floor, B wing, Centaur House, Opp. Grand Hyatt, Vakola, Santacruz – East, Mumbai - 400 055,India.
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Milind Jadhav
LifeSan Clinical Research, a division of Centaur Pharmaceuticals Pvt. Ltd.
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India. Mumbai (Suburban) MAHARASHTRA
Propiomazine is indicated to induce sleep in different types of sleep disorders.
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Reference product i.e. Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden.
One tablet of reference product i.e. Propiomazine Tablets 25 mg will be administered in period I or II as per randomization sequence generated by the biostatistician of LCR. Blood samples will be collected in K3EDTA vacutainers during period I and II as per following 25 time points under sodium vapor lamp: At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] and at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 and 48.000 hrs. after IMP administration. Total Duration of the study is at least 11 days.
Intervention
Test product i.e. Propiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd. India
One tablet of test product i.e. Propiomazine Tablets 25 mg will be administered in period I or II as per randomization sequence generated by the biostatistician of LCR. Blood samples will be collected in K3EDTA vacutainers during period I and II as per following 25 time points under sodium vapor lamp: At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] and at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 and 48.000 hrs. after IMP administration. Total Duration of the study is at least 11 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Healthy, Indian, male and/ or non-pregnant, non-lactating female, human volunteers aged from ≥ 18 to ≤ 45 years.
2. Weight not less than 50 Kg. and body mass index should be within 18.50–27.00 kg/m2 [weight in kg / (height in m)2].
3. Voluntarily willing and capable to give written and signed informed consent prior to participation in the study.
4. Availability for the entire study period and willingness to adhere to the protocol and study requirements.
5. Willing to undergo pre- and post-study physical examinations and laboratory investigations.
6. Having no current or past significant disease as well as clinically significant observations from medical history or physical examination or vital signs examination during screening.
7. Having normal values or clinically insignificant abnormal values of investigations of clinical laboratory examination during screening.
8. 12-lead supine ECG in resting position is within normal limits or showing clinically insignificant artifacts as per qualified medical staff.
9. Normal chest X-ray findings or findings that have no clinical correlation.
10. Having not consumed alcohol at least 24.000 hrs. prior to admission in the study justified by negative urine-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study.
11. Negative urine test for drug of abuse (amphetamine, barbiturate, tetrahydrocannabinoids, morphine, cocaine, benzodiazepine).
12. Not consumption of xanthine-containing derivatives [coffee, tea, cola drinks, chocolate] and grapefruit or orange or citrus fruits/ juice/ products for at least 48.000 hrs. prior to admission in the study.
13. Non-smokers [Definition – Those who do not have history of smoking or having quit smoking for more than 3 years].
14. Non-pregnant female Subject confirmed by negative serum β-hCG test [defined by value ≤ 5.7 mIU/mL] performed on the admission day.
15. Male Subjects of reproductive potential who agree to follow acceptable forms of contraception including – sexual abstinence and barrier methods [e.g. condoms] or those who have undergone vasectomy.
16. Female subject of reproductive potential agrees to remain abstinent or use highly effective contraception throughout the study.
17.Subjects who are of non-reproductive potential, i.e., Subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea).
ExclusionCriteria
Details
1. H/O allergy or sensitivity to propiomazine or phenothiazines or to any of the excipients of drug product, which, in the opinion of the investigator, would compromise the safety of the Subject.
2. History or presence of hepatic dysfunction established by elevated serum transaminases (SGOT/ SGPT) or alkaline phosphatase [at least 1.5 times of upper normal range].
3. History or presence of renal function impairment established by serum creatinine 1.5 times or more of upper reference range.
4. History or presence of any other clinically relevant systemic disease such as renal, hepatic, pulmonary, cardiac, gastrointestinal endocrine or metabolic disorder (e.g. diabetes mellitus, galactose intolerance, glucose-galactose malabsorption, lactose intolerance), malignancy or immunodeficiency disorder.
5. Irregular mealtimes, skipping meals, periods of fasting or dietary changes within last 3 months prior to enrollment in the study.
6. Participation in another clinical study or a blood donation program or having had blood loss of more than 450 mL during the last 90 days.
7. Seropositive for VDRL, HIV or hepatitis B or C infection.
8. Any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data, X-ray interpretation and full physical examination.
9. Vital sign abnormalities.
10. Having suffered any illness within a week of starting the study or who have been hospitalized within the 3 months preceding the start of the study.
11. Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug.
12. Having taken OTC or prescribed medications, including any enzyme-modifying drugs, antidepressants, hypnotics, barbiturates, opioids, other sedatives or any systemic medication [with the exception of contraceptive pills consumed by female volunteers], within the last 07 days prior to the study.
13. Having a history of alcohol or substance abuse within the last 5 years.
14. Habit of chewing or inhaling nicotine-containing products.
15. Abnormal INR combined with clinical manifestation
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To investigate bioequivalence of Test formulation of Propiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd., India against Reference formulation of Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden in healthy, adult, human Subjects following single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
Blood samples will be collected in K3EDTA vacutainers during period I and II (after 07 days of period I) as per following 25 time points i.e. At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] and at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 and 48.000 hrs. after IMP administration. Subject will be stay 48.000 hrs in both period.
Secondary Outcome
Outcome
TimePoints
1. To assess secondary PK parameters after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
2. To assess the safety & tolerability after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions in participating healthy Subjects.
Blood samples will be collected in K3EDTA vacutainers during period I & II (after 07 days of period I) as per following 25 time points i.e. At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] & at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 & 48.000 hrs. after IMP administration. Subject will be stay 48.000 hrs in both period.
Target Sample Size
Total Sample Size="40" Sample Size from India="40" Final Enrollment numbers achieved (Total)= "86" Final Enrollment numbers achieved (India)="86"
Phase of Trial
N/A
Date of First Enrollment (India)
06/02/2025
Date of Study Completion (India)
15/01/2026
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="0" Days="11"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Study Title: An open-label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover bioequivalence study of Propiomazine Tablets 25 mg [Test] of Centaur Pharmaceuticals Pvt. Ltd. India withPropavan® 25 mg (Propiomazine Tablets 25 mg) [Reference] of Sanofi-aventis AB, Stockholm, Sweden, in healthy, adult, human Subjects under fasting conditions.
Protocol no. LBS-054-23/1, version no. 01 dated 12-Dec-23
To investigate bioequivalence of Test formulation ofPropiomazine Tablets 25 mg of Centaur Pharmaceuticals Pvt. Ltd., India against Reference formulation of Propavan® 25 mg (Propiomazine Tablets 25 mg) of Sanofi-aventis AB, Stockholm, Sweden in healthy, adult, human Subjects following single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
To assess secondary PK parameters after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions.
To assess the safety and tolerability after single dose administration of 1 tablet of Test or Reference formulation under fasting conditions in participating healthy Subjects.
Number of Subject: This study will be conducted using a two-stage design.
First stage: Forty [40] healthy, adult, male and/ or non-pregnant, non-lactating female, human Subjects will be enrolled in this study.
Second stage (if required): Based on the results of first stage sample size re-estimation will be done using statistical SOP. Based on this revised sample size, additional number of Subjects will be enrolled.
Male and if enrolled, female Subjects would be admitted in separate groups.
Subject Selection criteria: For all volunteers – Eligible through screening examinations, inclusion criteria and exclusion criteria. Only for eligible female volunteers – a negative serum ß-hCG test on the day of admission in period I and II [Defined by value of ≤ 5.7 mIU/mL].
Dosing: One tablet of ‘Test’ or ‘Reference’ IMP will be administered at scheduled time as per the randomization schedule with 240 ± 2 mL of water at ambient temperature after suitability of the Subject is decided by the qualified medical staff.
Pharmacokinetic blood sampling: The concentration of propiomazine, R-propiomazine and S-propiomazine will be determined in plasma separated from venous blood samples collected in K3EDTA vacutainers during period I and II as per following 25 time points under sodium vapor lamp: At 0.000 hr. [pre-dose, collected within 1.000 hr. prior to scheduled dosing time] and at 0.167, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 30.000, 36.000 and 48.000 hrs. after IMP administration.
Total blood loss: Six [6] mL blood will be collected at each sampling time point. The total blood loss in this study would exceed 347.0 ± 10 mL for male volunteers and 351.0 ± 10 mL for female volunteers [if enrolled]. This blood loss includes blood loss for general and additional screening, PK sampling, PSSA and discarded blood.
Washout period: At least 07 days and Total duration of the study is 11 days.
Study is designed to conduct in the two stage.
Update of the study:
1st stage of the study was conducted on 40 trial participant in which 18 female [Group I] and 22 male [Group II].
Group I: 06-Feb-2025 to 09-Feb-2025 [Period I] & 13-Feb-2025 to 16-Feb-2025 [Period II]
Group II: 10-Feb-2025 to 13-Feb-2025 [Period I] & 17-Feb-2025 to 20-Feb-2025 [Period II]
2nd Stage of this study was conducted on 46 trial participant in which 20 female [Group I] and 26 male [Group II].
Group I: 29-Dec-2025 to 01-Jan-2026 [Period I] & 08-Jan-2026 to 11-Jan-2026 [Period II]
Group II: 05-Jan-2026 to 08-Jan-2026 [Period I] & 12-Jan-2026 to 15-Jan-2026 [Period II]