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

A Randomized,Open-label,Single Dose,Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Comparison to the Co-administration of Twynsta and Hygroton in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02496910

Enrollment

180

Registered

2015-07-14

Start date

2015-06-30

Completion date

2015-09-30

Last updated

2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

Detailed 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.

Interventions

DRUGYH22162

DRUGTelmisartan/Amlodipine 80/5 mg (FDC)

DRUGChlorthalidone 25mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Bioequivalence study is based on Cmax and AUC parameters	1 month

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026