NCT03609294

A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Hypertension
• Diabetes

Interventions

Type	Name	Description
DRUG	Treatment A (Fimasartan, Linagliptin)	Co-administration of Fimasartan and Linagliptin
DRUG	Treatment B (Fimasartan/Linagliptin)	Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Timeline

• Start date: 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 across 1 country: South Korea