KCT0000834
Recruiting
未知
An open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of HCP1201 tablet 750/20 mg and coadministration of metformin SR 750 mg and rosuvastatin 20 mg in healthy volunteers
Hanmi Pharm0 sites72 target enrollmentTBD
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Hanmi Pharm
- Enrollment
- 72
- Status
- Recruiting
- 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\) History of drug abuse or positive drug screening.
- •7\) Participation in other drug studies within 60days prior to the drug administration.
- •8\) Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
- •9\) Subjects who took prescription drugs within 14 days from the patient screening or non\-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
- •10\) Subjects who took medicines(e.g. proton pump inhibitor, rifampicin, oriental medicines, etc.) within 30days that can affect absorption, distribution, metabolism, elimination of metformin/rosuvastatin.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteersDiseases of the circulatory systemKCT0000786Hanmi Pharm12
Completed
Not Applicable
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 volunteersKCT0000985Hanmi Pharm72
Completed
Not Applicable
A randomized, open-label, single-dose, crossover study to compare the safety, tolerability and pharmacokinetics of ginsenosides after oral administrations of fermented Red ginseng concentrate and Red ginseng concentrate in healthy volunteersKCT0006791Kyung Hee University Hospital16
Completed
Not Applicable
The aim of this study is to compare and evaluate the pharmacokinetic properties and safety of oral administration of KD4002Endocrine, nutritional and metabolic diseasesKCT0007759Kyung Dong Pharmaceutical32
Completed
Not Applicable
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteersKCT0002471Jeil Pharmaceutical40