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

NCT01132027 | Completed Phase 1 DMC

• 1 other identifier: BA0859003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioavailability, crossover, tacrolimus

Outcome Measures

Primary Outcomes (1)

• Bioavailability study based on Cmax and AUC parameters

  3 months

Study Arms (2)

Tacrolimus

EXPERIMENTAL

Tacrolimus Capsules, 5 mg of Dr.Reddy's Laboratories Limited

Drug: Tacrolimus Capsules

Prograf Capsules

ACTIVE COMPARATOR

Prograf Capsules of Astellas Pharma US, Inc.,

Drug: Tacrolimus Capsules

Interventions

Tacrolimus Capsules DRUG

Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited

Also known as: Prograf capsules of Astellas Pharma US, Inc.,

Prograf Capsules; Tacrolimus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects should be healthy human between 18 and 45 years.
• The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
• The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
• The subjects should be able to communicate effectively with study personnel.
• The subjects should be able to give written informed consent to participate in the study.
• If subject is a female volunteer and
• 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.
• Is postmenopausal for at least 1 year.
• Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

You may not qualify if:

• The subjects who have a history of allergic responses to tacrolimus or other related drugs.
• The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings.
• 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.
• The subjects who have a history or presence of bronchial asthma.
• The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
• The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
• 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.
• The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
• The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
• The subjects who have a positive hepatitis screen (include subtypes A, B, C and E).
• The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
• 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.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breast-feeding.
• Female volunteers not willing to use contraception during the study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

BA Research India Limited

Ahmedabad, Gujarat, 380054, India

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Dr. Simran Sethi, MBBS

  BA Research India Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 14, 2010

Record last verified: 2010-06

Locations

IN (1)