Studying the safety and the pharmacokinetics after single dosing of KDF2001 in healthy adult
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009163
- Lead Sponsor
- Kyung Dong Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1) 19 years old or older at screening visit
2) weighed 50 kg or more (45 kg or more for female) with body-mass index of 18 to 30 kg/m^2 at screening visit
3) neither clinically significant congenital or chronic diseases, nor pathologic symptoms or findings in medical examinations at screening visit
4) eligible in laboratory tests and electrocardiogram
5) proper contraception for volunteer and his/her partners, restrictions of sperm or egg donation throughout the study
6) voluntary sign on informed consent form after fully understating the study.
1) clinically significant gastrointestinal, cardiovascular, endocrine, respiratory, hematologic, oncologic, infectious, nephrologic, urologic, psychologic, musculoskeletal, immunologic, otolaryngologic, dermatologic, or ophthalmologic diseases or history.
2) gastrointestinal surgery or disease affecting absorption of oral medications
3) drug metabolism inducers or inhibitors within 1 month, or clinical trial-interfering medications within 10 days
4) other investigational products withing 6 months
5) whole blood donation within 8 weeks, apheresis within 2 weeks, or blood transfusion within 4 weeks
6) following conditions within 1 month
6-1) alcohol consumption over 21 drinks per week for male, over 14 drinks per female
6-2) smoking over 20 cigarettes a day
7) following conditions
7-1) hypersensitivity to active ingredients or excipients of investigational products
7-2) galactose intolerance, Lapp lactase deficienty, or glucose-galactose malabsorption
8) following diseases
8-1) type 1 diabetes mellitus or diabetic ketoacidosis
8-2) glomerular filtration rate under 60 mL/min/1.73 m^2
8-2) end stage renal disease or dialysis
9) ineligible at the discretion of principal investigator due to reasons other than above criteria
10) pregnant or breast-feeding female
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax & AUCt of dapagliflozin, Cmax & AUCt of sitagliptin
- Secondary Outcome Measures
Name Time Method tmax, AUCinf, and half-life of dapagliflozin, tmax, AUCinf, and half-life of sitagliptin