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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03116516
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: Temisartan/Amlodipine+Rosuvastatin Drug: YHP1604 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A randomized, open-label, single dose, crossover clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : May 26, 2017
Actual Study Completion Date : May 26, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ARM1
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
All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.
Other Name: Twynsta Tab.+Crestor Tab.

Drug: YHP1604
All subjects will receive a single oral dose of YHP1604 administered in the morning.
Other Name: FDC

ARM2
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
All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.
Other Name: Twynsta Tab.+Crestor Tab.

Drug: YHP1604
All subjects will receive a single oral dose of YHP1604 administered in the morning.
Other Name: FDC




Primary Outcome Measures :
  1. Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast [ Time Frame: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs ]
    Cmax, AUClast



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy male with body mass index(BMI) between 18.5 and 30kg/m2
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116516


Locations
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Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of, 561-712
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Mingul Kim, MD Chonbuk National University Hospital
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT03116516    
Other Study ID Numbers: YHP1604-102
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors