A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2017-11-21
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boryung Pharmaceutical Co., Ltd
• Treatments: Linagliptin

Criteria

1. Inclusion Criteria (Total: 5):

1. 19-50 year-old healthy male.

2. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2

3. Subject who has no clinically significant medical history.

4. Subject whose informed consent is obtained and who is willing to comply with protocol.

2. Exclusion Criteria (Total: 19):

1. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or < 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or < 70mmHg

2. Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

3. Creatinine clearance(CrCl) < 80mL/min (using Cockcroft-Gault formula)

4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)

5. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).