Status:
COMPLETED
A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Hypertension
Eligibility:
MALE
19-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 1\. Inclusion Criteria (Total: 5):
- 19-50 year-old healthy male.
- 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2
- Subject who has no clinically significant medical history.
- Subject whose informed consent is obtained and who is willing to comply with protocol.
- 2\. Exclusion Criteria (Total: 19):
- Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or \< 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or \< 70mmHg
- Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
- Creatinine clearance(CrCl) \< 80mL/min (using Cockcroft-Gault formula)
- Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)
- Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).
Exclusion
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03250052
Start Date
August 14 2017
End Date
November 21 2017
Last Update
January 18 2018
Active Locations (1)
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1
Kyungpook National University Hospital
Seoul, South Korea