DP-R212 Pharmacokinetic Study

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

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An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.

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Detailed Description

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Conditions

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Hypertension Hyperlipidemias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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amplodipine group

Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

Amlodipine administration

Rosuvastatin

Intervention Type DRUG

Rosuvastatin administration

rosuvastatin group

Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

Amlodipine administration

Rosuvastatin

Intervention Type DRUG

Rosuvastatin administration

Interventions

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Amlodipine

Amlodipine administration

Intervention Type DRUG

Rosuvastatin

Rosuvastatin administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI 18-29
* signed the informed consent form prior to the study participation

Exclusion Criteria

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 14 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes