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

Phase 1

Completed

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Drug: Temisartan/Amlodipine+Rosuvastatin; Drug: YHP1604

• Registration Number: NCT03116516
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-17
• Study Start: 2017-04-21
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ARM1	Temisartan/Amlodipine+Rosuvastatin	In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
ARM1	YHP1604	In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
ARM2	Temisartan/Amlodipine+Rosuvastatin	In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
ARM2	YHP1604	In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.

Primary Outcome Measures

Name	Time	Method
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast	0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs	Cmax, AUClast

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of