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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02496910

YH22162-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

180 participants in 4 patient groups

Group 1 - Period 1

Active Comparator group

Description:

Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg

Treatment:

Drug: Telmisartan/Amlodipine 80/5 mg (FDC)

Drug: Chlorthalidone 25mg

Group 2 - Period 1

Experimental group

Description:

YH22162 FDC tablet of Yuhan Corporation

Treatment:

Drug: YH22162

Group 1 - Period 2

Experimental group

Description:

YH22162 FDC tablet of Yuhan Corporation

Treatment:

Drug: YH22162

Group 2 - Period 2

Active Comparator group

Description:

Telmisartan/Amlodipine 80/5 mg (FDC) and Chlorthalidone 25mg

Treatment:

Drug: Telmisartan/Amlodipine 80/5 mg (FDC)

Drug: Chlorthalidone 25mg