A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

Hypertension Clinical Trial

Official title:

A Phase 1, Open Label, Two-cohort, Single-Sequence, Crossover Study to Investigate the Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951962
• Other study ID #: YHP1604-101
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2016
• Last updated: January 31, 2017
• Start date: August 2016
• Est. completion date: September 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 phase 1, open label, two-cohort, single-sequence, crossover study

Description:

This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male with body mass index(BMI) between 18.5 and 28 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 due to reasons including laboratory test results, ECGs, or vital signs

• Sitting blood pressure meeting the following criteria at screening: 160 = systolic blood pressure =100 (mmHg) and 95 = diastolic blood pressure = 60 (mmHg)

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Drug:
• Twynsta 80/5mg
Hypertension
• Crestor 20mg
Hyperlipidemia

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, Amlodipine, Rosuvastatin AUCt		0 - 24 hr
Primary	Telmisartan, Amlodipine, Rosuvastatin Cmax		0 - 24 hr
Secondary	Telmisartan, Amlodipine, Rosuvastatin Tmax		0 - 24 hr
Secondary	Telmisartan, Amlodipine, Rosuvastatin Cmin		0 - 24 hr