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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Tacrolimus

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