DP-R212 Pharmacokinetic Study

Phase 1

• Conditions: Hypertension; Hyperlipidemias
• Interventions: Drug: Amlodipine; Drug: Rosuvastatin

• Registration Number: NCT02789475
• Lead Sponsor: Alvogen Korea

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amplodipine group	Rosuvastatin	Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
rosuvastatin group	Amlodipine	Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days
amplodipine group	Amlodipine	Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
rosuvastatin group	Rosuvastatin	Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days

Primary Outcome Measures

Name	Time	Method
AUCτ,ss of Amlodipine and Rosuvastatin	0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Cmax,ss of Amlodipine and Rosuvastatin	0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr

Trial Locations

Locations (1)

Inha university hospital; 🇰🇷 Jung-gu, Incheon, Korea, Republic of