| CTRI Number |
CTRI/2018/04/013202 [Registered on: 12/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
Bioequivalence study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study to see the effect of two drugs (fenspiride hydrochloride and pneumorel ) on healthy Human |
|
Scientific Title of Study
|
An open label, balanced, analyst blind, randomized, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Fenspiride hydrochloride extended release tablets 80 mg of Zuventus Healthcare Ltd. (A JV Company of Emcure Pharmaceuticals Ltd.) with Pneumorel® 80mg (Fenspiride hydrochloride tablets 80 mg) of Servier, France in normal, healthy, adult, human subjects under fasting condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMRI-106-13 version no 01 date 26th sept 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office No. 5119 5th Floor D Wing Oberoi Garden Estates Chandivali Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400 072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office No. 5119 5th Floor D Wing Oberoi Garden Estates Chandivali Andheri (E)
MAHARASHTRA
400 072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office No. 5119 5th Floor D Wing Oberoi Garden Estates Chandivali Andheri (E)
MAHARASHTRA
400 072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
| Zuventus Healthcare Limited
office no 5119 D wing 5th floor Oberoi Garden Estates Chandival Andheri East Mumbai 72 |
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
Office No. 5119, D Wing 5th Floor Oberoi Garden Estaes, Chandivali Andheri (E) Mumbai-400072 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Zuventus Healthcare Limited |
Office no 5119 D wing 5th Floor Oberoi Garden Estaes Chandival Andheri East Mumbai 72 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Gautam |
Drug Monitoring Research Institute (P) Ltd. |
R-374, MIDC, TTC Industrial Area, Rabale, Navi Mumbai 400 701
Thane
MAHARASHTRA |
022-39697979
022-39697999
umesh@panexcell.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksha Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy adult human subjects under fasting conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenspiride (80 mg) |
Fenspiride 80 mg tablet single dose for 1 day |
| Comparator Agent |
Pneumorel (80 mg) |
Pneumorel 80 mg tablet single dose for 1 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy human subjects within 18 - 45 years of age (both inclusive).
2.Non-pregnant, non-lactating (for females)
3.Body Mass Index of ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2.
4.Absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history or clinical examination.
5.Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
6.Have a normal chest X-ray PA view (if done)
7.Willingness to provide written informed consent to participate in the study, ability to comprehend the nature and purpose of the study.
8.Willingness to comply with the requirement of the protocol including all the restrictions.
9.Availability of subject for the entire study period.
|
|
| ExclusionCriteria |
| Details |
1.History of allergy or hypersensitivity to Investigational Product or to its excipients.
2.Clinically significant systemic or local disease.
3.History of epilepsy or psychiatric disorder.
4.Any illness within 21 days or hospitalized or a major illness within the 3 months prior to commencement of the study.
5.Any other clinical condition, which may affect the absorption, distribution, biotransformation or excretion of the study drug.
6.Presence of any of disease markers of HIV – 1 and 2, hepatitis B, C virus.
7.Use of any prescribed medication (including herbal or vitamin supplements) during last two weeks or OTC medical products during the last one week preceding the commencement of the study.
8.Participated in any other clinical investigation requiring repeated blood sampling / a blood donation program / have blood loss of more than 350 mL in the past 90 days
9.History of consumption of alcohol for more than two years & drink more than two alcoholic drinks per day or consumed alcohol within 48 hours prior to commencement of the study or difficulty in abstaining alcohol for the duration of the study. [one drink is equal to one unit of alcohol (one glass wine, half pint beer and one measure i.e. one fluid ounce of spirit)]
10.Smoke more than 10 cigarettes / day or Unable to abstain from smoking during the study.
11.Consumption of products containing xanthine & nicotine within 48 hours prior to commencement of the study.
12.Intake of grapefruits or products containing grapefruits within 72 hours prior to commencement of the study.
13.Any significant diet change (eg. low sodium diet) within four weeks prior commencement of the study.
14.Use of any recreational drug or a history of drug addiction.
15.History of difficulty in accessibility of veins in arms.
16.Female subjects not confirming to using birth control measures, from the date of screening until the completion of the last period of the study. [Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable].
17.Use of hormonal contraceptives either oral or implants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| C max,AUC 0-t, AUC 0-inf |
1.00 Hrs, 2.00 Hrs, 3.00 Hrs, 4.00 Hrs, 4.50 Hrs, 5.00 Hrs, 5.50 Hrs, 6.00 Hrs, 6.50 Hrs, 7.00 Hrs, 7.50 Hrs, 8.00 Hrs, 9.00 Hrs, 10.00 Hrs, 12.00 Hrs, 16.00 Hrs, 24.00 Hrs, 36 Hrs, 48.00 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tmax, T1/2, Kel |
1.00 Hrs, 2.00 Hrs, 3.00 Hrs, 4.00 Hrs, 4.50 Hrs, 5.00 Hrs, 5.50 Hrs, 6.00 Hrs, 6.50 Hrs, 7.00 Hrs, 7.50 Hrs, 8.00 Hrs, 9.00 Hrs, 10.00 Hrs, 12.00 Hrs, 16.00 Hrs, 24.00 Hrs, 36 Hrs, 48.00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
13/11/2014 |
| Date of Study Completion (India) |
22/11/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open label, balanced, analyst blind, randomized, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Fenspiride hydrochloride extended release tablets 80 mg of Zuventus Healthcare Ltd. (A JV Company of Emcure Pharmaceuticals Ltd.) with Pneumorel® 80mg (Fenspiride hydrochloride tablets 80 mg) of Servier, France in normal, healthy, adult, human subjects under fasting condition.Total Number of subjects participated 24 healthy human
objective is to compare single dose oral bioavailability profile of test product Fenspiride with pneumorel and to monitor safety
|