Hypertension Clinical Trial
Official title:
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
Verified date | February 2020 |
Source | Boryung Pharmaceutical Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | June 30, 2019 |
Est. primary completion date | March 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 50 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Dahak-ro |
Lead Sponsor | Collaborator |
---|---|
Boryung Pharmaceutical Co., Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | Maximum concentration of drug in plasma of Fimasartan, Linagliptin | Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration | |
Primary | AUClast | Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin | Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration |
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