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

Phase 1

Completed

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

• Registration Number: NCT02951962
• Lead Sponsor: Yuhan Corporation

Brief Summary

This is a phase 1, open label, two-cohort, single-sequence, crossover study

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-21
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted QC: 2016-10-30
• Study First Posted: 2016-11-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Twynsta 80/5mg	Twynsta 80/5mg	Day 1 \~ Day 9 : Twynsta 80/5mg / Day 10 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Crestor 20mg	Twynsta 80/5mg	Day 1 \~ Day 5 : Crestor 20mg / Day 6 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Twynsta 80/5mg	Crestor 20mg	Day 1 \~ Day 9 : Twynsta 80/5mg / Day 10 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg
Crestor 20mg	Crestor 20mg	Day 1 \~ Day 5 : Crestor 20mg / Day 6 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Primary Outcome Measures

Name	Time	Method
Telmisartan, Amlodipine, Rosuvastatin Cmax	0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin AUCτ	0 - 24 hr

Secondary Outcome Measures

Name	Time	Method
Telmisartan, Amlodipine, Rosuvastatin Tmax	0 - 24 hr
Telmisartan, Amlodipine, Rosuvastatin Cmin	0 - 24 hr

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Chunju, Korea, Republic of