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COMPLETEDPhase 1NCT03609294

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

Lead sponsor: Boryung Pharmaceutical Co., Ltd•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Boryung Pharmaceutical Co., Ltd

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.

Age

19 - 50 years

Sex

MALE

Healthy Volunteers

Yes

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 5, 2020Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment67

Start dateJul 2018

Last updatedFeb 5, 2020

Condition

Hypertension Diabetes

Locations shown

Seoul National University Hospital

Seoul, Dahak-ro

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2020Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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