PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

Phase 1TerminatedNCT02608242

Yuhan Corporation123 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Hypertension Hyperlipidemia

Interventions

YH22189DRUG

Twynsta 80/10mgDRUG

Crestor 20mgDRUG

Eligibility

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

Medical Language ↔ Plain English

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)

Locations (1)

Chonbuk National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

Telmisartan Cmax

Time frame: 0 - 72 hrs

Telmisartan AUClast

Time frame: 0 - 72 hrs

Amlodipine Cmax

Time frame: 0 - 168 hrs

Amlodipine AUClast

Time frame: 0 - 168 hrs

Rosuvastatin Cmax

Time frame: 0 - 48 hrs

Rosuvastatin AUClast

Time frame: 0 - 48 hrs

Data from ClinicalTrials.gov

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