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

Information source: Yuhan Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: YH22162 (Drug); Telmisartan/Amlodipine 80/5 mg (FDC) (Drug); Chlorthalidone 25mg (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Yuhan Corporation

Official(s) and/or principal investigator(s):
Mingul Kim, MD, Ph.D, Principal Investigator, Affiliation: Chonbuk National University Hospital

Overall contact:
Mingul Kim, MD, Ph.D, Email: mgkim@jbctc.org

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Bioequivalence study is based on Cmax and AUC parameters

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.

Eligibility

Minimum age: 19 Years. Maximum age: 50 Years. Gender(s): Male.

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)

Locations and Contacts

Mingul Kim, MD, Ph.D, Email: mgkim@jbctc.org

Chonbuk National University Hospital, Chunju 561-712, Korea, Republic of; Recruiting
Mingul Kim, MD, Ph.D, Email: mgkim@jbctc.org
Additional Information

Starting date: June 2015
Last updated: July 14, 2015

Page last updated: August 23, 2015

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