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

Yuhan Corporation180 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

180

Conditions

Hypertension

Interventions

YH22162DRUG

Telmisartan/Amlodipine 80/5 mg (FDC)DRUG

Chlorthalidone 25mgDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Chonbuk National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

Bioequivalence study is based on Cmax and AUC parameters

Time frame: 1 month

Data from ClinicalTrials.gov

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