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OpenTrials
Completed

NCT Number: NCT02496910

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

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

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Key information

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

YH22162

Drug

Telmisartan/Amlodipine 80/5 mg (FDC)

Drug

Other names: Twinstar 80/5 mg

Chlorthalidone 25mg

Drug

Other names: Hygroton 25mg

Primary outcomes

  1. Bioequivalence study is based on Cmax and AUC parameters

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2015
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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