Diabetes Mellitus
Conditions
Brief summary
An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects
Interventions
DRUGTeneligliptin+Glimepiride
Sponsors
Handok Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male adult aged 20 to 45 years 2. Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening 3. 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. 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) | 24hr |
| Area under the plasma concentration versus time curve (AUC) | 24hr |
Outcome results
None listed