DP-R212 Pharmacokinetic Study

Alvogen Korea38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Hyperlipidemias

Interventions

AmlodipineDRUG

Amlodipine administration

RosuvastatinDRUG

Rosuvastatin administration

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Inha university hospital

Jung-gu, Incheon, South Korea

RECRUITING

Outcomes

Primary Outcomes

AUCτ,ss of Amlodipine and Rosuvastatin

Time frame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr

Cmax,ss of Amlodipine and Rosuvastatin

Time frame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr

Central Contacts

Chul woo Kim, Ph.D.

CONTACT

82-92-890-1168 cwkim1805@inha.ac.kr

Data from ClinicalTrials.gov

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