Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01080469
• Date of registration: 02/03/2010
• Prospective Registration: No
• Primary sponsor: Panacea Biotec Ltd
• Public title: Bioequivalence Study of Tacrolimus 1 mg Capsule Under Fed Condition
• Scientific title: A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 1 mg in Normal Healthy Male Subjects Under Fed Condition
• Date of first enrolment: September 2007
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01080469
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr. Suhas Khandave
• Affiliation: Accutest Research Laboratories (I) Pvt. Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male subjects in the range of age from 18 to 55 years.

2. Body weight within ± 15% of ideal weight as related to height and body frame
according to Life Insurance Corporation (LIC) Chart. (Appendix A)

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

4. Subjects with normal findings as determined by Haemogram with ESR,
Biochemistry,Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and
Urinalysis, ECG, X-ray (X-ray if taken).

5. Willingness to follow the protocol requirement as evidenced by written, informed
consent.

6. Agreeing to, not using any medication prescription and over the counter medications
including vitamins and minerals for 14 days prior to study & during the course of the
study.

7. No history or presence of significant alcoholism or drug abuse in the past one year.

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."

Exclusion Criteria:

1. Requiring medication for any ailment including enzyme-modifying drugs in the previous
28 days, before day 1 of dosing.

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

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

4. Participation in a clinical drug study or bioequivalence study 90 days prior to
present study.

5. History or presence of malignancy or other serious diseases.

6. Refusal to abstain from food for at least ten (10) hours prior to administration of
the study drug and for four (4) additional hours each, post dose during each study
period.

7. Any contraindication to blood sampling.

8. Refusal to abstain from water for at least one (1) hour prior to study drug
administration on dosing day of each study period and for at least two (2) additional
hours, post dosing except 240 mL administered during administration of the dose.

9. Use of xanthine-containing beverages or food and grapefruit or grapefruit products
for 48 hours prior to each drug dose.

10. Blood donation 90 days prior to the commencement of the study.

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

12. Subjects having contradiction or hypersensitivity to Tacrolimus or related group of
drugs or any excipients of the products.

13. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
dosing until last sample collection of each period.

14. Found positive in Breath alcohol test done at the time of screening or on the day of
enrollment for each study period or for every ambulatory sample.

15. History or presence of problem in swallowing tablets or capsules.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: Tacrolimus 1 mg Capsule

Primary Outcome(s)

To demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 1 mg manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 1 mg manufactured by Astellas Pharma, Inc., USA [Time Frame: up to 3 days]

Secondary ID(s)

US/07/053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors