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

Not Applicable

Completed

• Conditions: Immunosuppression
• Interventions: Drug: Tacrobell capsule 1mg; Drug: Prograf capsule 1mg

• Registration Number: NCT01910077
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Study Start: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tacrobell capsule 1mg	Tacrobell capsule 1mg	Tacrolimus 1mg / 1 capsule
Prograf capsule 1mg	Prograf capsule 1mg	Tacrolimus 1mg / 1 capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of