A drug-drug interaction clinical study to investigate the effects of Bojungikgi-tang and Pingwei-san on the pharmacokinetics of Metformin, Dapagliflozin and Sitagliptin tablets in healthy male volunteers
- Conditions
- Not Applicable
- Registration Number
- KCT0009124
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 16
1)Healthy male volunteers aged 19 to 45 (at the time of consent of the subject)
2)Subjects weighing more than 50 kg and less than 90 kg, with body mass index (BMI) greater than 18.0 and less than 29.0 ? (BMI (kg/m2) = Weight (kg) / {Height (m)}2)
3)Subjects who have received and fully understood the detailed explanation of this clinical trial and have voluntarily decided to participate and agreed in writing to comply with the precautions
4)Subjects judged by researchers to be healthy based on screening tests (physical examination, clinical laboratory examination, questionnaire, etc.)
1)Those with a history of clinically significant liver, digestive system, circulatory system, kidney, nervous system, respiratory system, endocrine system, immune system, blood system, tumor, psychiatric history or substance abuse
2)A person who is hypersensitive to clinical trial drugs or a series of drugs such as clinical trial drugs
3)Those who fall under the contraindications within the clinical trial drug license (such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption)
4)Gastrointestinal diseases (Cron's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery that may affect the absorption of clinical trial drugs (However, Those who have a history of simple appendectomy or hernia surgery)
5)A person who shows the following results at the time of a screening inspection
?Those who show the systolic blood pressure = of 150 mmHg or = 90 mmHg or the diastolic blood pressure = of 100 mmHg or = 60 mmHg in vital signs measured from the upper seat after resting for at least 3 minutes
?Those with a liver level (AST, ALT) in serum at least 1.5 times the upper limit of normal in clinical laboratory tests for evaluating liver function
?The blood creatinine level exceeds the reference range, or the eGFR calculated by the Modification of Diet in Renal Disease (MDRD) formula is 60mL/min/1.If it is less than 73 m2
?Subjects whose serological test results (HBs antigen, HCV antibody, and HIV antibody and RPR test) are positive or beyond the reference range
6)Persons who have used or are obliged to use the following food or medicine during the period specified below
?Those who have continuously taken/intake drugs and foods known as CYP enzyme inducers or inhibitors within 4 weeks prior to the first dosing date
?A person who has taken any prescription drug or herbal medicine that may affect the characteristics of the clinical trial drug within two weeks prior to the first administration date, or has taken any over-the-counter drug (OTC) or vitamin within one week, If the drug does not affect the pharmacokinetic properties of the clinical trial drug, it may participate in the clinical trial at the discretion of the tester.)
?A person who has taken a drug metabolite-inducing and inhibiting drug such as barbiturant drugs within one month prior to the first administration date or who has taken a drug that may interfere with the test within 10 days prior to the first administration date
? A person who has consumed grapefruit or grapefruit-containing food from 72 hours before the first dose to the end of the study or who cannot prohibit it
?A person who has consumed caffeine or caffeine-containing food from 72 hours before the first dose to the end of the study or who cannot prohibit it
?Consistent drinking within 6 months prior to the first dosing date (21 units/week excess, 1 unit = 10 g = 12.A person who has done 5 mL of pure alcohol) or cannot abstain from drinking from the time of written consent to the end of the study
7)Those who have participated in other drug clinical trials or biological equivalence trials within six months prior to the first administration date and received medications (but the criteria for the end of participation in other drug clinical trials or biological equivalence trials shall be calculated as one day after the last administration date).)
8)Those who are not allowed to use contraceptive methods (e.g. administering and transplanting contraceptives
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC (Part 1: Metformin, Part 2: Dapagliflozin, Part 3: Sitagliptin) ;Gmax, AUG(Metformin) / Cumulative urine glucose(Dapagliflozin) / DPP-4 inhibtion(Sitagliptin)
- Secondary Outcome Measures
Name Time Method Cardiac biomarker;liver biomarker;kidney biomarker;Pharmcogenomics