A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
| Registry | NCT03609294 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, other |
| Enrollment | 67 (Actual) |
| Sponsor | Boryung Pharmaceutical Co., Ltd (Industry) |
| Conditions | Hypertension, Diabetes |
| Interventions | Treatment A (Fimasartan, Linagliptin), Treatment B (Fimasartan/Linagliptin) (Drug) |
| Dates | start 2018-07-18, primary completion 2019-03-04, completion 2019-06-30, first posted 2018-08-01, last updated 2020-02-05 |
| Locations | 1 site in South Korea |
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The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sequence A | Experimental | Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin) | Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period. |
| Sequence B | Experimental | Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin) | Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period. |
| Sequency C | Experimental | Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin) | Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period. |
Sex: Male, ages: 19 Years to 50 Years, accepts healthy volunteers
Inclusion Criteria: 1. Male 19-50 years of age. 2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening. 3. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol. 4. Medically healthy with no clinically significant medical history. Exclusion Criteria: 1. History or presence of clinically significant medical or psychiatric condition or disease. 2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). 3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening. 4. Plasma donation within a month prior to the first dose of study drug. 5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul, Dahak-ro | South Korea |