NCT01910077

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Immunosuppression

Interventions

Type	Name	Description
DRUG	Tacrobell capsule 1mg	1 capsule, oral, over the period I\&II(crossover)
DRUG	Prograf capsule 1mg	1 capsule, oral, over the period I\&II(crossover)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2013-07-29
• Last updated: 2014-07-23

Locations

1 site across 1 country: South Korea