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Completed

NCT Number: NCT03609294

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Dahak-ro, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male 19-50 years of age.
  • Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
  • Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
  • Medically healthy with no clinically significant medical history.

Exclusion criteria

  • History or presence of clinically significant medical or psychiatric condition or disease.
  • Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  • Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
  • Plasma donation within a month prior to the first dose of study drug.
  • Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Treatment and study plan

Treatment A (Fimasartan, Linagliptin)

Drug

Co-administration of Fimasartan and Linagliptin

Treatment B (Fimasartan/Linagliptin)

Drug

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Primary outcomes

  1. Cmax

    Time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration

    Maximum concentration of drug in plasma of Fimasartan, Linagliptin

  2. AUClast

    Time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration

    Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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