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

A Phase I 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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: (fimasartan or linagliptin) x 7days; Drug: (fimasartan and linagliptin) x 7days

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

1. Inclusion Criteria (Total: 5):

1. 19-50 year-old healthy male.
2. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2
3. Subject who has no clinically significant medical history.
4. Subject whose informed consent is obtained and who is willing to comply with protocol.

2. Exclusion Criteria (Total: 19):

1. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or < 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or < 70mmHg
2. Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
3. Creatinine clearance(CrCl) < 80mL/min (using Cockcroft-Gault formula)
4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)
5. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days	Drug: (fimasartan or linagliptin) x 7days; Part A: fimasartan, Part B: linagliptin; Drug: (fimasartan and linagliptin) x 7days; Part A & Part B: Co-administration of fimasartan and linagliptin
Experimental: Part B; Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days	Drug: (fimasartan or linagliptin) x 7days; Part A: fimasartan, Part B: linagliptin; Drug: (fimasartan and linagliptin) x 7days; Part A & Part B: Co-administration of fimasartan and linagliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Young-Ran Yoon, PhD, Kyungpook National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): October 13, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Fimasartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin
• Other Study ID Numbers: BR-FLC-CT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No