Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg

NCT ID: NCT01910077

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2013-11-30

Brief Summary

The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.

Detailed Description

This will be an open label, randomized, single dose, 2-treatment, 2-period crossover study in healthy volunteers.Study treatments will be administered under fasting conditions.

Blood samples for the analysis of tacrolimus in blood will be obtained as follows: Predose(immediately prior to dosing), and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours postdose.

Conditions

Immunosuppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrobell capsule 1mg

Tacrolimus 1mg / 1 capsule

Group Type: EXPERIMENTAL

Tacrobell capsule 1mg

Intervention Type: DRUG

1 capsule, oral, over the period I\&II(crossover)

Prograf capsule 1mg

Tacrolimus 1mg / 1 capsule

Group Type: ACTIVE_COMPARATOR

Prograf capsule 1mg

Intervention Type: DRUG

1 capsule, oral, over the period I\&II(crossover)

Interventions

Tacrobell capsule 1mg

1 capsule, oral, over the period I\&II(crossover)

Intervention Type: DRUG

Prograf capsule 1mg

1 capsule, oral, over the period I\&II(crossover)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed the informed consent from prior to screening test
• Between 19 years and 55 years in healthy male subject
• Have not any congenital or chronic disease and medical symptoms
• Body mass index(BMI) of 18 to 30 and a total body weight ≥ 55kg
• Appropriate subject for the study judging from investigator

Exclusion Criteria

• Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine
• Any condition possibly affecting drug absorption (e.g. gastrectomy)
• Subject with hypersensitivity to tacrolimus or any excipient
• Administration of cyclosporin or bosentan
• Administration of potassium-sparing diuretics
• Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• SBP<90 mmHg or DBP<50 mmHg, SBP>150 mmHg or DBP>100 mmHg at least 3 minutes of rest
• A positive HBsAg, HCV Ab, HIV Ab, RPR
• AST, ALT > 1.5*upper limit of normal range at the screening test
• Subject with a history of drug abuse or a positive reaction for drug abuse at the screening test
• Taking ETC medicine including oriental medicine within 14days before the first hospitalization or taking OTC medicine, vitamin within 7days
• Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initiation test
• Participating in a bioequivalence study or other clinical study within 3 month preceding the first hospitalization
• Blood donation or more within 2 month or component blood donation within 1 month prior to the first hospitalization
• Continued to be drinking(alcohol> 21 units/week, 1 unit=10g of pure alcohol) or during clinical trials can not be drunk
• Severe heavy smoker(cigarette> 10 cigarettes/day) during 3 months or can not be smoking during the clinical study
• Continued to be taking caffeine or can not be taken caffeine
• Continued to be taking grapefruit or can not be taken grapefruit
• Not use of contraception during the clinical study
• An impossible one who participates in the clinical trial by investigator's decision including for reason of laboratory test result

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeong Ki Lee, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul national university hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Tacrobell_BE-1301

Identifier Type: -

Identifier Source: org_study_id