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

Chong Kun Dang

Status

Completed

Conditions

Immunosuppression

Treatments

Drug: Tacrobell capsule 1mg

Drug: Prograf capsule 1mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910077

Tacrobell_BE-1301

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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