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

NCT03116516 | Completed Phase 1

• 1 other identifier: YHP1604-102
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast

  Cmax, AUClast

  0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs

Study Arms (2)

ARM1

OTHER

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

Drug: Temisartan/Amlodipine+Rosuvastatin; Drug: YHP1604

ARM2

OTHER

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

Drug: Temisartan/Amlodipine+Rosuvastatin; Drug: YHP1604

Interventions

Temisartan/Amlodipine+Rosuvastatin DRUG

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

Also known as: Twynsta Tab.+Crestor Tab.

ARM1; ARM2

YHP1604 DRUG

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

Also known as: FDC

ARM1; ARM2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: Healthy male with body mass index(BMI) between 18.5 and 30kg/m2
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mingul Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, open-label, single dose, crossover clinical trial

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: April 21, 2017
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)