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

An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Tacrobell Capsule 1mg Versus Prograf Capsule 1mg in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Immunosuppression
• Intervention / Treatment: Drug: Tacrobell capsule 1mg; Drug: 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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tacrobell capsule 1mg; Tacrolimus 1mg / 1 capsule	Drug: Tacrobell capsule 1mg; 1 capsule, oral, over the period I&II(crossover)
ACTIVE_COMPARATOR: Prograf capsule 1mg; Tacrolimus 1mg / 1 capsule	Drug: Prograf capsule 1mg; 1 capsule, oral, over the period I&II(crossover)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast	AUClast: Area under the blood concentration-time profile from time zero to the time of the last quantifiable concentration	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	Cmax: Maximum blood concentration	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	ACUinf: Area under the blood concentration-time profile from time zero extrapolated to infinite time	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	Tmax: Time for 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 postdose
T1/2	T1/2: Terminal elimination half-life	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	CL/F: Apparent Clearance	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Hyeong Ki Lee, MD, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (ESTIMATE): July 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: bioequivalence; tacrolimus; tacrobell capsule; prograf capsule
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: Tacrobell_BE-1301