Overview

Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Tetrabenazine
Criteria
Inclusion Criteria:

1. Male and non pregnant female human subjects, age in the range of 18-45 years both
inclusive.

2. Body mass index within the range of 18.5 kg/m2- 24.99 kg/m2 extremes included and body
weight > 50 kg.

3. Subjects with normal findings as determined by baseline history, physical examination
and vital signs examination (blood pressure, pulse rate, respiration rate and axillary
temperature).

4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry,
urinalysis, 12 lead ECG.

5. Willingness to follow the protocol requirements especially abstaining from xanthine
containing food or beverages (chocolates, tea, coffee or cola drinks) or use of
grapefruit juice, any alcoholic products, the use of cigarettes and 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 for the last 6 months.

8. Non-smokers, ex-smokers and moderate smokers were included. "Moderate smokers are
defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who
completely stopped smoking for at least 3 months."

9. Willing to use an acceptable, effective method of contraception.

10. Subject must be literate, able to sign their name, and able to give voluntary written
informed consent for the trial

11. Able to read and understand the Informed Consent Form and Medication guide either in
its original form (i.e. in English) or translated into a regional language

Exclusion Criteria:

1. Subject is illiterate.

2. Subjects with a history of depression or prior suicide attempts or ideation

3. Known history of hypersensitivity to Tetrabenazine or related drugs.

4. Requiring medication for any ailment having enzyme-modifying activity in the previous
28 days, prior to dosing day.

5. Subjects who have taken prescription medications or over-the-counter products
(including vitamins and minerals) within 14 days prior to administration of
Investigational Product.

6. Any medical or surgical conditions, which might significantly interfere with the
functioning of gastrointestinal tract, blood-forming organs etc.

7. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,
metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric
diseases.

8. Participation in a clinical drug study or bioequivalence study 90 days prior to
Period-I dosing of the present study.

9. History of malignancy or other serious diseases.

10. Blood donation 90 days prior to period I dosing of the present study.

11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.

12. Found positive in urine test for drug abuse.

13. History of problem in swallowing.

14. Any contraindication to blood sampling.

15. Found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.

16. Lactating women (currently breast feeding).

17. 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.

18. Use of hormonal contraceptives either oral or implants