Status:
COMPLETED
Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Immunosuppression
Eligibility:
MALE
19-55 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01910077
Start Date
August 1 2013
End Date
November 1 2013
Last Update
July 23 2014
Active Locations (1)
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1
Seoul national university hospital
Seoul, South Korea