We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

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: NCT02496910
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
This is a Randomized, open-label, single-dose, 2-treatment, 2-period, 2-sequence crossover design.

Condition or disease Intervention/treatment Phase
Hypertension Drug: YH22162 Drug: Telmisartan/Amlodipine 80/5 mg (FDC) Drug: Chlorthalidone 25mg Phase 1

Detailed Description:

This is a 2 by 2 cross-over study to evaluate pharmacokinetics of YH22162 FDC compared to reference twynsta and Hygroton co-administered in two 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 YH22162 FDC or twynsta and Hygroton co-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 two treatment periods will be separated by a washout period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1 - Period 1
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Drug: Telmisartan/Amlodipine 80/5 mg (FDC)
Other Name: Twinstar 80/5 mg

Drug: Chlorthalidone 25mg
Other Name: Hygroton 25mg

Experimental: Group 2 - Period 1
YH22162 FDC tablet of Yuhan Corporation
Drug: YH22162
Experimental: Group 1 - Period 2
YH22162 FDC tablet of Yuhan Corporation
Drug: YH22162
Active Comparator: Group 2 - Period 2
Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg
Drug: Telmisartan/Amlodipine 80/5 mg (FDC)
Other Name: Twinstar 80/5 mg

Drug: Chlorthalidone 25mg
Other Name: Hygroton 25mg




Primary Outcome Measures :
  1. Bioequivalence study is based on Cmax and AUC parameters [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
  2. Who has not suffered from clinically significant disease
  3. Provision of signed written informed consent

Exclusion Criteria:

  1. History of and clinically significant disease
  2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
  3. Administration of other investigational products within 3 months prior to the first dosing.
  4. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
  5. 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): NCT02496910


Locations
Layout table for location information
Korea, Republic of
Chonbuk National University Hospital
Chunju, Korea, Republic of, 561-712
Sponsors and Collaborators
Yuhan Corporation
Investigators
Layout table for investigator information
Principal Investigator: Mingul Kim, MD, Ph.D Chonbuk National University Hospital
Layout table for additonal information
Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02496910    
Other Study ID Numbers: YH22162-102
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Chlorthalidone
Telmisartan amlodipine combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors