KCT0000985
Completed
未知
An open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of HCP1201 tablet 500/10 mg and coadministration of metformin SR 500 mg and rosuvastatin 10 mg in healthy volunteers
Hanmi Pharm0 sites72 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hanmi Pharm
- Enrollment
- 72
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Healthy male volunteer, age 20\~55 years
- •2\) The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- •3\) Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •4\) Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria
- •1\) Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- •2\) Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- •3\) Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- •4\) SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower thatn 60mmHg or higher than 100mmHg
- •5\) History of relevant drug allergies or clinically significant hypersensitivity reaction.
- •6\) Subjects who judged ineligible by the investigator.
Outcomes
Primary Outcomes
Not specified
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