Overview
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2019-06-30
2019-06-30
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Boryung Pharmaceutical Co., LtdTreatments:
Linagliptin
Criteria
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).