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

NCT ID: NCT02608242

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-06-30

Brief Summary

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

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.

Conditions

Hypertension; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

YH22189

YH22189 FDC tablet of Yuhan Corporation

Group Type: EXPERIMENTAL

YH22189

Intervention Type: DRUG

Twynsta 80/10mg

Telmisartan/Amlodipine 80/10mg (FDC)

Group Type: ACTIVE_COMPARATOR

Twynsta 80/10mg

Intervention Type: DRUG

Crestor 20mg

Rosuvastatin 20mg

Group Type: ACTIVE_COMPARATOR

Crestor 20mg

Intervention Type: DRUG

Interventions

YH22189

Intervention Type: DRUG

Twynsta 80/10mg

Intervention Type: DRUG

Crestor 20mg

Intervention Type: DRUG

Other Intervention Names

Telmisartan/Amlodipine 80/10mg(FDC); Rosuvastatin 20mg

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonbuk National University Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

YH22189-102

Identifier Type: -

Identifier Source: org_study_id