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

NCT03250052 | Completed Phase 1

• 1 other identifier: BR-FLC-CT-101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Fimasartan

Outcome Measures

Primary Outcomes (4)

• [Part A] AUC of fimasartan

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

  0~24 hour after drug administration

• [Part A] Cmax of fimasartan

  \[Part A\] Cmax of fimasartan in steady state

  0~24 hour after drug administration

• [Part B] AUC of Linagliptin

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

  0~24 hour after drug administration

• [Part B] Cmax of linagliptin

  \[Part B\] Cmax of linagliptin in steady state

  0~24 hour after drug administration

Study Arms (2)

Part A

EXPERIMENTAL

Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days

Drug: (fimasartan or linagliptin) x 7days; Drug: (fimasartan and linagliptin) x 7days

Part B

EXPERIMENTAL

Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days

Drug: (fimasartan or linagliptin) x 7days; Drug: (fimasartan and linagliptin) x 7days

Interventions

(fimasartan or linagliptin) x 7days DRUG

Part A: fimasartan, Part B: linagliptin

Part A; Part B

(fimasartan and linagliptin) x 7days DRUG

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

Part A; Part B

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year-old healthy male.
• kg/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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Kyungpook National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020.

  PMID: 32546973 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Linagliptin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Officials

• Young-Ran Yoon, PhD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: August 14, 2017
• Primary Completion: October 13, 2017
• Study Completion: November 21, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)