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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Twynsta 80/5mg

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

Group Type EXPERIMENTAL

Twynsta 80/5mg

Intervention Type DRUG

Hypertension

Crestor 20mg

Intervention Type DRUG

Hyperlipidemia

Crestor 20mg

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

Group Type EXPERIMENTAL

Twynsta 80/5mg

Intervention Type DRUG

Hypertension

Crestor 20mg

Intervention Type DRUG

Hyperlipidemia

Interventions

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Twynsta 80/5mg

Hypertension

Intervention Type DRUG

Crestor 20mg

Hyperlipidemia

Intervention Type DRUG

Other Intervention Names

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Telmisartan/Amlodipine 80/5mg Rosuvastatin 20mg

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes