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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes
• Intervention / Treatment: Drug: Treatment A (Fimasartan, Linagliptin); Drug: Treatment B (Fimasartan/Linagliptin)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dahak-ro
    • Seoul, Dahak-ro, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 willing and able to comply with the protocol.
4. Medically healthy with no clinically significant medical history.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
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 of study drug(s).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A; Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.	Drug: Treatment A (Fimasartan, Linagliptin); Co-administration of Fimasartan and Linagliptin; Drug: Treatment B (Fimasartan/Linagliptin); Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg
Experimental: Sequence B; Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.	Drug: Treatment A (Fimasartan, Linagliptin); Co-administration of Fimasartan and Linagliptin; Drug: Treatment B (Fimasartan/Linagliptin); Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg
Experimental: Sequency C; Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.	Drug: Treatment A (Fimasartan, Linagliptin); Co-administration of Fimasartan and Linagliptin; Drug: Treatment B (Fimasartan/Linagliptin); Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration of drug in plasma of Fimasartan, Linagliptin	Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
AUClast	Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin	Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): March 4, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Fimasartan; Linagliptin
• 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-102

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