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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116516
• Other study ID #: YHP1604-102
• Status: Completed
• Phase: Phase 1
• Start date: April 21, 2017
• Est. completion date: May 26, 2017

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

Intervention

Drug:
• Temisartan/Amlodipine+Rosuvastatin
All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.
• YHP1604
All subjects will receive a single oral dose of YHP1604 administered in the morning.

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast	Cmax, AUClast	0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs