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

Hypertension Clinical Trial

Official title:

A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02608242
• Other study ID #: YH22189-102
• Status: Terminated
• Phase: Phase 1
• First received: November 11, 2015
• Last updated: January 31, 2017
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 123
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• YH22189

• Twynsta 80/10mg

• Crestor 20mg

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Chunju

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telmisartan Cmax		0 - 72 hrs
Primary	Telmisartan AUClast		0 - 72 hrs
Primary	Amlodipine Cmax		0 - 168 hrs
Primary	Amlodipine AUClast		0 - 168 hrs
Primary	Rosuvastatin Cmax		0 - 48 hrs
Primary	Rosuvastatin AUClast		0 - 48 hrs