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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Twynsta 80/5mg; Drug: Crestor 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02951962

YHP1604-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Twynsta 80/5mg

Experimental group

Description:

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

Treatment:

Drug: Crestor 20mg

Drug: Twynsta 80/5mg

Crestor 20mg

Experimental group

Description:

Day 1 \~ Day 5 : Crestor 20mg / Day 6 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Treatment:

Drug: Crestor 20mg

Drug: Twynsta 80/5mg