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

Last updated: February 3, 2020
Sponsor: Boryung Pharmaceutical Co., Ltd
Overall Status: Completed

Phase

1

Condition

Diabetic Macular Edema

Diabetic Foot Ulcers

Diabetic Gastroparesis

Treatment

N/A

Clinical Study ID

NCT03609294
BR-FLC-CT-102
  • Ages 19-50
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 willingand able to comply with the protocol.

  4. Medically healthy with no clinically significant medical history.

Exclusion

Exclusion Criteria:

  1. History or presence of clinically significant medical or psychiatric condition ordisease.

  2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis Bsurface antigen (HBsAg) or hepatitis C virus (HCV).

  3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg atscreening.

  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 ofstudy drug(s).

Study Design

Total Participants: 67
Study Start date:
July 18, 2018
Estimated Completion Date:
June 30, 2019

Study 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.

Connect with a study center

  • Seoul National University Hospital

    Seoul, Dahak-ro 03080
    Korea, Republic of

    Site Not Available

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