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Completed

NCT Number: NCT03250052

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Seoul, South Korea

About this study

This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.

Who can participate

Healthy volunteers accepted: Yes

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

  • 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.
  • 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).

Treatment and study plan

(fimasartan or linagliptin) x 7days

Drug

Part A: fimasartan, Part B: linagliptin

(fimasartan and linagliptin) x 7days

Drug

Part A & Part B: Co-administration of fimasartan and linagliptin

Primary outcomes

  1. [Part A] AUC of fimasartan

    Time frame: 0~24 hour after drug administration

    [Part A] Area under the curve(AUC) of fimasartan in steady state

  2. [Part A] Cmax of fimasartan

    Time frame: 0~24 hour after drug administration

    [Part A] Cmax of fimasartan in steady state

  3. [Part B] AUC of Linagliptin

    Time frame: 0~24 hour after drug administration

    [Part B] Area under the curve(AUC) of Linagliptin in Steady State

  4. [Part B] Cmax of linagliptin

    Time frame: 0~24 hour after drug administration

    [Part B] Cmax of linagliptin in steady state

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Jan 18, 2018

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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