KCT0000999
Completed
未知
Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects
Chong Kun Dang0 sites24 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Endocrine, nutritional and metabolic disease
- Sponsor
- Chong Kun Dang
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) A healthy male volunteer between 19 and 55 years old.
- •2\) BMI between 19 and 27\.
- •3\) Signed the informed consent form prior to study participation.
- •4\) Able to participate in the entire trial
Exclusion Criteria
- •1\) Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor
- •2\) Clinically significant hemorrhagic disease
- •3\) Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose\-galactose malabsorption
- •4\) Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics
- •5\) Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening
- •6\) Participated in the other clinical trials and administrated IP within 60 days prior to screening
- •7\) Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening
- •8\) Previously donate whole blood within 60 days or component blood within 30 days
- •9\) sit SBP \< 90mmHg or sit SBP \= 140mmHg or sit DBP \< 60mmHg or sit DBP \= 90mmHg
- •10\) A heavy alcohol consumer (alcohol \> 140 g/week) or cannot stop drinking
Outcomes
Primary Outcomes
Not specified
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