KCT0000837Completed未知
Bioequivalence study of Tacrobell capsule 1mg to Prograf capsule 1mg.
Chong Kun Dang0 sites50 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 19(Year) to 55(Year) (—)
- Sex
- Male
Inclusion Criteria
- •1. Signed the informed consent from prior to screening test
- •2. Between 19 years and 55 years in healthy male subject
- •3. Have not any congenital or chronic disease and medical symptoms
- •4. Body mass index(BMI) of 18 to 30 and a total body weight = 55kg
- •5. Appropriate subject for the study judging from investigator
Exclusion Criteria
- •1. Evidence or history of clinically significant hepatic, renal, neurologic, immune system, respiratory system, endocrine
- •2. Any condition possibly affecting drug absorption (e.g. gastrectomy)
- •3. Subject with hypersensitivity to tacrolimus or any excipient
- •4. Administration of cyclosporin or bosentan
- •5. Administration of potassium-sparing diuretics
- •6. Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •7. SBP<90 mmHg or DBP<50 mmHg, SBP>150 mmHg or DBP>100 mmHg at least 3 minutes of rest
- •8. A positive HBsAg, HCV Ab, HIV Ab, RPR
- •9. AST, ALT > 1.5*upper limit of normal range at the screening test
- •10 Subject with a history of drug abuse or a positive reaction for drug abuse at the screening test
- •11. Taking ETC medicine including oriental medicine within 14days before the first hospitalization or taking OTC medicine, vitamin within 7days
- •12. Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initiation test
- •13. Participating in a bioequivalence study or other clinical study within 3 month preceding the first hospitalization
- •14. Blood donation or more within 2 month or component blood donation within 1 month prior to the first hospitalization
- •15. Continued to be drinking(alcohol> 21 units/week, 1 unit=10g of pure alcohol) or during clinical trials can not be drunk
- •16. Severe heavy smoker(cigarette> 10 cigarettes/day) during 3 months or can not be smoking during the clinical study
- •17. Continued to be taking caffeine or can not be taken caffeine
- •18. Continued to be taking grapefruit or can not be taken grapefruit
- •19. Not use of contraception during the clinical study
- •20. An impossible one who participates in the clinical trial by investigator's decision including for reason of laboratory test result
Investigators
Similar Trials
Completed
Not Applicable
Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mgImmunosuppressionNCT01910077Chong Kun Dang Pharmaceutical50
Recruiting
Not Applicable
In-vivo Bioequivalence Test of Ticagrelor® tablet with brand drugs (BRILINTA® AstraZeneca UK).IRCT20200105046010N31ABIDI Pharmaceutical Company24
Recruiting
Not Applicable
In-vivo Bioequivalence Test of Ticagrelor® tablet with brand drugs (BRILINTA® AstraZeneca UK).IRCT20200105046010N28ARENA Pharmaceutical Company24
Completed
Not Applicable
Bioequivalence study of Ticagrelor 90mgIRCT20200623047902N9Kimia Ara Heram company24
Not yet recruiting
Unknown
Comparative in vivo evaluation of 2 Ticagrelor 90 mg F.C. Tablet and Brilinta® 90 mg F.C. Tablet formulations.ong term (current) use of antithrombotics/antiplatelets.Long term (current) use of antithrombotics/antiplateletsZ79.02IRCT20180620040164N54Zist Arvand Pharme Ltd.24