Immunosuppression
Conditions
Keywords
tacrolimus, tacrobell capsule, prograf capsule, bioequivalence
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.
Interventions
DRUGTacrobell capsule 1mg
1 capsule, oral, over the period I&II(crossover)
DRUGPrograf capsule 1mg
1 capsule, oral, over the period I&II(crossover)
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | At pre-dose (immediately prior to dosing) and 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 postdese | AUClast: Area under the blood concentration-time profile from time zero to the time of the last quantifiable concentration |
| Cmax | At pre-dose (immediately prior to dosing) and 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 postdese | Cmax: Maximum blood concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf | At pre-dose (immediately prior to dosing) and 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 | ACUinf: Area under the blood concentration-time profile from time zero extrapolated to infinite time |
| Tmax | At pre-dose (immediately prior to dosing) and 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 | Tmax: Time for Cmax |
| T1/2 | At pre-dose (immediately prior to dosing) and 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 | T1/2: Terminal elimination half-life |
| CL/F | At pre-dose (immediately prior to dosing) and 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 | CL/F: Apparent Clearance |
Countries
South Korea
Outcome results
None listed