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

C

Chong Kun Dang

Status

Completed

Conditions

Immunosuppression

Treatments

Drug: Tacrobell capsule 1mg
Drug: Prograf capsule 1mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01910077
Tacrobell_BE-1301

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Tacrobell capsule 1mg
Experimental group
Description:
Tacrolimus 1mg / 1 capsule
Treatment:
Drug: Tacrobell capsule 1mg
Prograf capsule 1mg
Active Comparator group
Description:
Tacrolimus 1mg / 1 capsule
Treatment:
Drug: Prograf capsule 1mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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