A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Hypertension
- Interventions
- Drug: (fimasartan or linagliptin) x 7daysDrug: (fimasartan and linagliptin) x 7days
- Registration Number
- NCT03250052
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.
- Detailed Description
This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 39
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B (fimasartan or linagliptin) x 7days Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days Part A (fimasartan and linagliptin) x 7days Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days Part B (fimasartan and linagliptin) x 7days Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days Part A (fimasartan or linagliptin) x 7days Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days
- Primary Outcome Measures
Name Time Method [Part A] AUC of fimasartan 0~24 hour after drug administration \[Part A\] Area under the curve(AUC) of fimasartan in steady state
[Part A] Cmax of fimasartan 0~24 hour after drug administration \[Part A\] Cmax of fimasartan in steady state
[Part B] AUC of Linagliptin 0~24 hour after drug administration \[Part B\] Area under the curve(AUC) of Linagliptin in Steady State
[Part B] Cmax of linagliptin 0~24 hour after drug administration \[Part B\] Cmax of linagliptin in steady state
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kyungpook National University Hospital
🇰🇷Seoul, Korea, Republic of