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COMPLETEDPHASE1

Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers

NCT03116516•Yuhan Corporation

View on ClinicalTrials.gov

Summary

This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.

Detailed Description

This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers. In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22. In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.

Eligibility

Age

19 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
•Who has not suffered from clinically significant disease
•Provision of signed written informed consent

Exclusion Criteria

•History of and clinically significant disease
•A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
•Administration of other investigational products within 3 months prior to the first dosing

Locations (1)

Chonbuk National University Hospital

Jeonju, South Korea

Key Dates

Start Date

April 21, 2017

Primary Completion Date

May 26, 2017

Completion Date

May 26, 2017

Last Updated

January 16, 2019

Enrollment

ACTUAL participants

Conditions

HypertensionHyperlipidemia

Interventions

Temisartan/Amlodipine+Rosuvastatin

DRUG

YHP1604

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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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: January 16, 2019Data synced to Clareo: March 29, 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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Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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