NCT01910077

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

Same day

First QC Date

July 24, 2013

Last Update Submit

July 21, 2014

Conditions

Immunosuppression

Keywords

tacrolimustacrobell capsuleprograf capsulebioequivalence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Tacrobell capsule 1mg

EXPERIMENTAL

Tacrolimus 1mg / 1 capsule

Drug: Tacrobell capsule 1mg

Prograf capsule 1mg

ACTIVE COMPARATOR

Tacrolimus 1mg / 1 capsule

Drug: Prograf capsule 1mg

Interventions

Tacrobell capsule 1mgDRUG

1 capsule, oral, over the period I\&II(crossover)

Tacrobell capsule 1mg
Prograf capsule 1mgDRUG

1 capsule, oral, over the period I\&II(crossover)

Prograf capsule 1mg

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Hyeong Ki Lee, MD, Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 29, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

November 1, 2013

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

KR(1)