CTRI/2017/08/009514 [Registered on: 28/08/2017] Trial Registered Retrospectively
Last Modified On:
30/03/2019
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence Study of Clonazepam mouth dissolving tablets 2 mg under Fasting Conditions
Scientific Title of Study
A Randomized, Open Label, Balanced, Two Treatment, Two period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Clonazepam mouth dissolving tablets 2 mg of Abbott Healthcare Pvt ltd., with Clonazepam 2 mg immediate release tablets of Abbott Healthcare Pvt ltd., in Normal, Healthy, Adult, Male and Female Human Subjects under Fasting Conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ARL/16/410 Version 01 dated 18 November 2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Vandana Sahlam
Designation
Principal Investigator
Affiliation
Accutest Research Laboratories (I) Pvt. Ltd
Address
Clinical Department, A31, M.I.D.C, T.T.C Industrial Area, Khairane, Navi Mumbai 400709,
Maharashtra, INDIA
Mumbai (Suburban)
MAHARASHTRA
400709
India
Mumbai (Suburban) MAHARASHTRA 400709 India
Phone
02227780718
Fax
02227780720
Email
vandana.sahlam@accutestglobal.com
Details of Contact Person Scientific Query
Name
Dr Vandana Sahlam
Designation
Principal Investigator
Affiliation
Accutest Research Laboratories (I) Pvt. Ltd
Address
Clinical Department, A31, M.I.D.C, T.T.C Industrial Area, Khairane, Navi Mumbai 400709,
Maharashtra, INDIA
Mumbai (Suburban)
MAHARASHTRA
400709
India
Mumbai (Suburban) MAHARASHTRA 400709 India
Phone
02227780718
Fax
02227780720
Email
vandana.sahlam@accutestglobal.com
Details of Contact Person Public Query
Name
Dr Shubhangi Desai
Designation
Associate Director, Clinical Operations and Pharmacovigilance
Affiliation
Abbott Healthcare Pvt. Ltd.
Address
Department: Clinical Operations, Medical Affairs, Floor 16, Godrej BKC, Plot No. C68, BKC, Near MCA Club, Bandra
(E) Mumbai400 051 India
Mumbai
MAHARASHTRA
400051
India
Male and non pregnant female human subjects,
age in the range of 18 – 45 years both inclusive
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Clonazepam 2 mg Immediate
Release Tablet
Clonazepam 2 mg Immediate
Release Tablet
Intervention
Clonazepam Mouth Dissolving
Tablets 2 mg
Clonazepam Mouth Dissolving
Tablets 2 mg
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Male and non pregnant female human subjects, age in the range of 18 – 45 years both inclusive.
2. Body Mass Index between 18.5-30 Kg / m2 extremes included.
3. Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done).
5. Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in each study period and adherence to food, fluid and posture restrictions.
6. No history of significant alcoholism.
7. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix B) for the last 06 months.
8. Non smokers as evident from the history obtained will be included.
ExclusionCriteria
Details
1. Known history of hypersensitivity to Clonazepam or related drugs.
2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
3. Subjects who have taken prescription medications or over-the-counter products (including vitamins and minerals) within 14 days prior to administration of IMP.
4. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs etc.
5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
6. Participation in a clinical drug study or bioequivalence study 90 days prior to period I dosing of the present study.
7. History of malignancy or other serious diseases.
8. Blood donation 90 days prior to period I dosing of the present study.
9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
10. Found positive in breath alcohol test.
11. Found positive in urine test for drug abuse.
12. History of problem in swallowing.
13. Any contraindication to blood sampling.
14. Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
15. Lactating women (currently breast feeding).
16. Female subjects not confirming to using birth control measures, from the date of screening until the completion 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
Pharmacy-controlled Randomization
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To demonstrate the bioequivalence between Test Product (T): Clonazepam Mouth Dissolving Tablets 2 mg and Reference Product (R): Clonazepam 2 mg Immediate Release Tablet in normal, healthy, adult, male and female human subjects, under fasting conditions.
Total number of blood samples: 23 per period.
Sampling hrs: Pre dose (collected within 01.00 hour prior to dosing), 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
Secondary Outcome
Outcome
TimePoints
To monitor the safety and tolerability of a single oral dose of investigational medicinal products (IMPs).
Total number of blood samples: 23 per period.
Sampling hrs: Pre dose (collected within 01.00 hour prior to dosing), 00.25, 00.50, 00.75, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 08.00, 12.00, 16.00, 24.00, 48.00 and 72.00 hrs post dose.
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "30" Final Enrollment numbers achieved (India)="30"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Clonazepamis indicated for the treatment of myoclonic and a kinetic seizures and petit mal variant (Lennox-Gastaut syndrome). The recommended dose range of Clonazepam tablets is 2 mg once daily with or without food. The safety and efficacy of Clonazepam tablets 2 mgwhen given as a single dose, in healthy volunteers is established through various clinical studies. As per the literature single oral dose of Clonazepamtablets 2 mgresults in quantifiable levels. The present study will be conducted under fasting condition based on the recommendation of regulatory authority. This dose is expected to be well tolerated and will provide sufficient plasma concentrations to measure. Based on this rationale, the current study has been designed.