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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01132027
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Tacrolimus Capsules
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioavailability study based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Prograf capsules of Astellas Pharma US, Inc.,

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132027

Locations
India
BA Research India Limited
Ahmedabad, Gujrat, India, 380054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Simran Sethi, MBBS BA Research India Limited
  More Information

No publications provided

Responsible Party: Dr. Ramesh Mullangi/Director - R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01132027     History of Changes
Other Study ID Numbers: BA0859003
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability, crossover, tacrolimus

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014