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

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910077
• Other study ID #: Tacrobell_BE-1301
• Status: Completed
• Phase: N/A
• First received: July 24, 2013
• Last updated: July 21, 2014
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2014
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunosuppression

Intervention

Drug:
• Tacrobell capsule 1mg
1 capsule, oral, over the period I&II(crossover)
• Prograf capsule 1mg
1 capsule, oral, over the period I&II(crossover)

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No