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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Amlodipine; Chlorthalidone; Telmisartan; Telmisartan amlodipine combination

Criteria

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)