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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

May 26, 2010
June 11, 2010
January 2008
February 2008   (final data collection date for primary outcome measure)
Bioavailability study based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Bioavailability study based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01132027 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Tacrolimus Capsules
Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
Other Name: Prograf capsules of Astellas Pharma US, Inc.,
  • Experimental: Tacrolimus
    Tacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited
    Intervention: Drug: Tacrolimus Capsules
  • Active Comparator: Prograf Capsules
    Prograf Capsules of Astellas Pharma US, Inc.,
    Intervention: Drug: Tacrolimus Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01132027
BA0859003
Yes
Dr. Ramesh Mullangi/Director - R&D, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Dr. Simran Sethi, MBBS BA Research India Limited
Dr. Reddy's Laboratories Limited
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP