Diabetes Mellitus Clinical Trial
NCT number | NCT03009513 |
Other study ID # | MP_C103 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | June 2017 |
Verified date | April 2018 |
Source | Handok Pharmaceuticals Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects
Status | Completed |
Enrollment | 26 |
Est. completion date | June 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
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. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Handok Pharmaceuticals Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak Plasma Concentration (Cmax) | 24hr | ||
Primary | Area under the plasma concentration versus time curve (AUC) | 24hr |
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