| CTRI Number |
CTRI/2022/02/040093 [Registered on: 08/02/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet with VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet in healthy adult human subjects under fasting conditions. |
|
Scientific Title of Study
|
An Open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult human subjects under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/014/0619 version 01 dated 05 Nov 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naresh |
| Designation |
Principal investigator |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16&18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore-560097 India.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore-560097 India.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Operation Director |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore-560097 India.
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| The ACME Laboratories Ltd.
Court de la ACME 1/4, Kallayanpur, Mirpur road,
Dhaka- 1207, Bangladesh.
|
|
|
Primary Sponsor
|
| Name |
The ACME Laboratories Ltd |
| Address |
Court de la ACME 1/4, Kallayanpur, Mirpur road,
Dhaka- 1207, Bangladesh.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naresh |
ICBio Clinical Research Pvt. Ltd. |
#16&18 ICBio Tower, Yelahanka Main Road,
Chikkabetahalli, Vidyaranyapura
Bangalore-560097 India.
Bangalore
KARNATAKA |
9900111997
pi.mail@icbiocro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult human subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet |
Single tablet of 35 mg of Trimetazidine Hydrochloride one time only |
| Intervention |
WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet |
Single tablet of 35 mg Trimetazidine Hydrochloride one time only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy human subjects aged from 18 to 55 years, both ages inclusive.
2.BMI range from 18 to 30 kg/m2 inclusive with the body weight ≥ 45 kgs.
3.Normal vital signs [blood pressure (Systolic 90-140 mmHg, Diastolic 60-90mmHg), pulse rate 60-100 beats/min), respiratory rate (15-20 breaths/min) and body temperature (96.0-99.8oF)].
4.Normal medical and surgical history as evaluated by the physician or principal investigator prior to start of the study.
5.Normal 12-lead electrocardiogram (ECG) & chest X-Ray (P/A view).
|
|
| ExclusionCriteria |
| Details |
1.Contraindications or Hypersensitivity to Trimetazidine or to any of the components of the formulation or excipients.
2.History of Acute or chronic metabolic acidosis, Severe ketosis, diabetic coma or history of diabetic coma, type 1 diabetic patients
3.History of severe infection, surgery, severe trauma (blood sugar control should preferably be done by insulin).
4.History of Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
5.History or presence of any disease (Gastric, renal, respiratory, cardiac, neurological etc.) according to the opinion of the physician.
6.History or presence of significant alcoholism or drug abuse in the past one year.
7.History or presence of significant smoking (more than 09 cigarettes or bidis/day) or consumption of tobacco products (pan, gutkha) and refusal to restrain from smoking for 48.00 hours before first period check-in until last sample collection.
8.History or presence of significant asthma, urticaria or other allergic reactions.
9.History of difficulty in donating blood or difficulty in accessibility of veins.
10.Difficulty in swallowing oral dosage forms.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare bioequivalence of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult human subjects under fasting conditions. |
From day 1 to Day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor and assess safety and tolerability of the investigational products in healthy adult, human subjects under fasting condition |
From day 1 to Day 10 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2022 |
| Date of Study Completion (India) |
14/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Open label,
balanced, randomized, two-treatment, two-period, two-sequence, single oral dose,
crossover, bioequivalence study of WHILST (Trimetazidine Hydrochloride) 35 mg
Modified Release Tablet of The ACME Laboratories Ltd., with VASTAREL® (Trimetazidine)
MR 35 mg Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in
healthy adult human subjects under fasting conditions.
Primary
objective:
To compare bioequivalence
of WHILST (Trimetazidine Hydrochloride) 35 mg Modified Release Tablet of The
ACME Laboratories Ltd., with VASTAREL® (Trimetazidine) MR 35 mg
Modified release tablet of LES LABORATORIES SERVIER INDUSTRIE in healthy adult
human subjects under fasting conditions.
Secondary
objective:
To monitor and assess
safety and tolerability of the investigational products in healthy adult, human
subjects under fasting condition. |