Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Brief Summary

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A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

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Detailed Description

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Conditions

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Hypertension and Dyslipidemia

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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Reference1

single(Reference1) -\> combination(Reference1+Reference2)

Group Type EXPERIMENTAL

Telmisartan

Intervention Type DRUG

Amlodipine

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Reference2

single(Reference2) -\> combination(Reference1+Reference2)

Group Type EXPERIMENTAL

Telmisartan

Intervention Type DRUG

Amlodipine

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Interventions

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Telmisartan

Intervention Type DRUG

Amlodipine

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male who are ≥19, \<50 years old
* Man who weights over 55kg and whose BMI is 18\~30(kg/m2)
* Man who doesn't have any chronic disease or history of disease

Exclusion Criteria

* man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes