Teneligliptin-Glimepiride DDI Study
Phase 1
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Drug: Teneligliptin+Glimepiride
- Registration Number
- NCT03009513
- Lead Sponsor
- Handok Inc.
- Brief Summary
An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 26
Inclusion Criteria
- Healthy male adult aged 20 to 45 years
- Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening
- Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
- Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm Teneligliptin+Glimepiride -
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) 24hr Area under the plasma concentration versus time curve (AUC) 24hr
- Secondary Outcome Measures
Name Time Method