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

Phase 1

Completed

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

• Registration Number: NCT03609294
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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.

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 Timeline

• Study Start: 2018-07-18
• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Primary Completion: 2019-03-04
• Study Completion: 2019-06-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Treatment A (Fimasartan, Linagliptin)	Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.
Sequence A	Treatment B (Fimasartan/Linagliptin)	Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.
Sequence B	Treatment A (Fimasartan, Linagliptin)	Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Sequence B	Treatment B (Fimasartan/Linagliptin)	Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Sequency C	Treatment A (Fimasartan, Linagliptin)	Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Sequency C	Treatment B (Fimasartan/Linagliptin)	Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.

Primary Outcome Measures

Name	Time	Method
Cmax	Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration	Maximum concentration of drug in plasma of Fimasartan, Linagliptin
AUClast	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Dahak-ro, Korea, Republic of