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

Yuhan

Status and phase: Terminated; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: YH22189; Drug: Crestor 20mg; Drug: Twynsta 80/10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02608242

YH22189-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 123 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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123 participants in 3 patient groups

YH22189

Experimental group

Description:

YH22189 FDC tablet of Yuhan Corporation

Treatment:

Drug: YH22189

Twynsta 80/10mg

Active Comparator group

Description:

Telmisartan/Amlodipine 80/10mg (FDC)

Treatment:

Drug: Twynsta 80/10mg

Crestor 20mg

Active Comparator group

Description:

Rosuvastatin 20mg

Treatment:

Drug: Crestor 20mg