Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fasting Condition

NCT01080482 | Completed

• 1 other identifier: US/07/054
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma, Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.

Conditions

Healthy Volunteers

Keywords

Bioequivalence study in healthy volunteers

Outcome Measures

Primary Outcomes (1)

• To demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg manufactured by Astellas Pharma, Inc., USA

  up to 3 days

Study Arms (2)

Prograf® Capsule 5 mg

ACTIVE COMPARATOR

Drug: Tacrolimus 5 mg Capsule

Tacrolimus Capsule 5 mg

EXPERIMENTAL

Drug: Tacrolimus 5 mg Capsule

Interventions

Tacrolimus 5 mg Capsule DRUG

Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule

Also known as: Tacrolimus Capsule

Prograf® Capsule 5 mg; Tacrolimus Capsule 5 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects in the range of age from 18 to 55 years.
• Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart. (Appendix A)
• Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and axillary temperature).
• 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).
• Willingness to follow the protocol requirement as evidenced by written, informed consent.
• 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.
• No history or presence of significant alcoholism or drug abuse in the past one year.
• 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."

You may not qualify if:

• Requiring medication for any ailment including enzyme-modifying drugs in the previous 28 days, before day 1 of dosing.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History or presence of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
• Participation in a clinical drug study or bioequivalence study 90 days prior to present study.
• History or presence of malignancy or other serious diseases.
• 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.
• Any contraindication to blood sampling.
• 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.
• Use of xanthine-containing beverages or food and grapefruit or grapefruit products for 48 hours prior to each drug dose.
• Blood donation 90 days prior to the commencement of the study.
• Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
• Subjects having contradiction or hypersensitivity to Tacrolimus or related group of drugs or any excipients of the products.
• Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period.
• 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.
• History or presence of problem in swallowing tablets or capsules.

Sponsors & Collaborators

• Panacea Biotec Ltd: lead

Study Sites (1)

Accutest Research Laboratories (I) Pvt. Ltd.

Navi Mumbai, Maharashtra, 400 709, India

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Dr. Suhas Khandave

  Accutest Research Laboratories (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: September 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: March 4, 2010

Record last verified: 2010-03

Locations

IN (1)