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

NCT ID: NCT03116516

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-21
• Study Completion Date: 2017-05-26

Brief 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.

Conditions

Hypertension; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM1

In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.

Group Type: OTHER

Temisartan/Amlodipine+Rosuvastatin

Intervention Type: DRUG

All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.

YHP1604

Intervention Type: DRUG

All subjects will receive a single oral dose of YHP1604 administered in the morning.

ARM2

In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.

Group Type: OTHER

Temisartan/Amlodipine+Rosuvastatin

Intervention Type: DRUG

All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.

YHP1604

Intervention Type: DRUG

All subjects will receive a single oral dose of YHP1604 administered in the morning.

Interventions

Temisartan/Amlodipine+Rosuvastatin

All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.

Intervention Type: DRUG

YHP1604

All subjects will receive a single oral dose of YHP1604 administered in the morning.

Intervention Type: DRUG

Other Intervention Names

Twynsta Tab.+Crestor Tab.; FDC

Eligibility Criteria

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
• Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mingul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Chonbuk National University Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

YHP1604-102

Identifier Type: -

Identifier Source: org_study_id