Bioavailability Study of Tacrolimus Capsules, 5 mg of Dr. Reddys's Laboratories Limited Under Non-Fasting Conditions

An Open Label, Two Way Crossover, Balanced, Single Dose, Comparative Evaluation of Relative Bioavailability of Tacrolimus Capsules 5 mg With That of 'Prograf' Capsules 5 mg in Healthy Subjects Under Non-fasting Conditions.

The purpose of this study is to compare the relative bioavailability study of tacrolimus capsules 5 mg with prograf capsules 5 mg in healthy, adult, human subjects under non-fasting conditions and to monitor safety of subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tacrolimus Capsules

Detailed Description

An open label, randomized, two period, two treatment, two sequence, crossover, balanced, single dose, comparative evaluation of relative bioavailability of tacrolimus capsules 5 mg with that of 'prograf' capsules 5 mg in healthy adult human subjects under non-fasting conditions.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Gujrat
    • Ahmedabad, Gujrat, India, 380054
      • BA Research India Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subjects should be healthy human between 18 and 45 years.
2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
4. The subjects should be able to communicate effectively with study personnel.

5. The subjects should be able to give written informed consent to participate in the study.

   If subject is a female volunteer and

6. Is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms,foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
7. Is postmenopausal for at least 1 year.
8. Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria:

1. The subjects who have a history of allergic responses to tacrolimus or other related drugs.
2. The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings.
3. The subjects who have any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
4. The subjects who have a history or presence of bronchial asthma.
5. The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
6. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
7. The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
8. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
9. The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
10. The subjects who have a positive hepatitis screen (include subtypes A, B, C and E).
11. The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
12. The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication application.
13. Female volunteers demonstrating a positive pregnancy screen.
14. Female volunteers who are currently breast-feeding.
15. Female volunteers not willing to use contraception during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus; Tacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited	Drug: Tacrolimus Capsules; Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited; Other Names: Prograf capsules of Astellas Pharma US, Inc.,
Active Comparator: Prograf Capsules; Prograf Capsules of Astellas Pharma US, Inc.,	Drug: Tacrolimus Capsules; Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited; Other Names: Prograf capsules of Astellas Pharma US, Inc.,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioavailability study based on Cmax and AUC parameters	3 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Dr. Simran Sethi, MBBS, BA Research India Limited

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 14, 2010
• Last Update Submitted That Met QC Criteria: June 11, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Bioavailability, crossover, tacrolimus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: BA0859003