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PK Study of YH22189 FDC Compared to Combination 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: NCT02608242
Recruitment Status : Terminated (sponsor decision)
First Posted : November 18, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Condition or disease Intervention/treatment Phase
Hypertension Hyperlipidemia Drug: YH22189 Drug: Twynsta 80/10mg Drug: Crestor 20mg Phase 1

Detailed Description:

This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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 YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
Actual Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: YH22189
YH22189 FDC tablet of Yuhan Corporation
Drug: YH22189
Active Comparator: Twynsta 80/10mg
Telmisartan/Amlodipine 80/10mg (FDC)
Drug: Twynsta 80/10mg
Other Name: Telmisartan/Amlodipine 80/10mg(FDC)

Active Comparator: Crestor 20mg
Rosuvastatin 20mg
Drug: Crestor 20mg
Other Name: Rosuvastatin 20mg




Primary Outcome Measures :
  1. Telmisartan Cmax [ Time Frame: 0 - 72 hrs ]
  2. Telmisartan AUClast [ Time Frame: 0 - 72 hrs ]
  3. Amlodipine Cmax [ Time Frame: 0 - 168 hrs ]
  4. Amlodipine AUClast [ Time Frame: 0 - 168 hrs ]
  5. Rosuvastatin Cmax [ Time Frame: 0 - 48 hrs ]
  6. Rosuvastatin AUClast [ Time Frame: 0 - 48 hrs ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female with a body mass index(BMI) between 18.5 and 25 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 (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
  • Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

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): NCT02608242


Locations
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Korea, Republic of
Chonbuk National University Hospital
Chunju, Korea, Republic of, 561-712
Sponsors and Collaborators
Yuhan Corporation

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02608242    
Other Study ID Numbers: YH22189-102
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Amlodipine
Telmisartan
Telmisartan amlodipine combination
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
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists