Clinical trial NCT01910077: Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Tacrobell Capsule 1mg Versus Prograf Capsule 1mg in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunosuppression
Keywords: tacrolimus
tacrobell capsule
prograf capsule
bioequivalence
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 50
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: AUClast
timeFrame: 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
measure: Cmax
timeFrame: 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
Secondary outcomes:
measure: AUCinf
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: T1/2
timeFrame: 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
measure: CL/F
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyeong Ki Lee, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: