A Randomized, Open Label, Two Treatment, Four period, Two Sequence, Full Replicate, Single Dose, Crossover Bioequivalence Study of Entacapone GPO (200 mg) (Entacapone 200 mg Tablets) of The Government Pharmaceutical Organization, with Comtan (Entacapone 200 mg Tablets) of Orion Corporation, Finland for Novatis Pharma AG, Switzerland, in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions

Phase 1

• Conditions: Healthy male and female volunteers

• Registration Number: TCTR20200302001
• Lead Sponsor: The Government Pharmaceutical Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Study Completion: 2020-05-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Male and non-pregnant female human subjects, age in the range of 18 †45 years
both inclusive.
2. Body Mass Index between 18-30 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 haematology,
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 72.00 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. A recent history of harmful use of alcohol
(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per
week for men and more than 7 standard drinks per week for women (A standard
drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled
spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic
products within 48 hours prior to dosing in Period-I.
7. No history of drug abuse (morphine, cannabinoids, amphetamine, cocaine,
benzodiazepines and barbiturates) for the last one month and other illegal drugs
(Appendix B) for the last 06 months.
8. Non-smokers, ex-smokers and moderate smokers will be 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. For female: Subject is child bearing potential practicing acceptable method of
birth control for the duration of the study as judged by Investigator such as
Condom, Foams, Jellies, Diaphragm and Abstinence.
OR
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
hysterectomy has been performed on the subject).

Exclusion Criteria

1. Known history of hypersensitivity to Entacapone or related drugs or peanut or
soya or any of excipients.
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, bloodâ€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. Subjects requiring mental alertness and motor coordination, such as driving a
motor vehicle or operating machine?
15. History or presence of seizure or psychiatric disorder.
16. An unusual diet, for whatever reason (for example, fasting, high potassium or
low-sodium), for four weeks prior to receiving the study drug in period I. In any
such case subject selection will be at the discretion of the Principal Investigator.
17. Subjects with Orthostatic hypotension i.e.,-Sitting blood pressure less than 100/60
mm of Hg, or pulse rate less than 60 per minute or more than 100 beats per minute
18. Female subjects found positive serum (β) Beta- hCG (Human Chorionic
Gonadotropin) test.
19. Lactating women (currently breast feeding).
20. 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.
21. Use of hormonal contraceptives either oral or implants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified