DP-R212 Pharmacokinetic Study

Alvogen

Status and phase: Unknown; Phase 1

Conditions: Hypertension; Hyperlipidemias

Treatments: Drug: Rosuvastatin; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02789475

DP-CTR-212-I-01

Details and patient eligibility

About

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

Enrollment: 38 estimated patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

amplodipine group

Experimental group

Description:

Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days

Treatment:

Drug: Rosuvastatin

Drug: Amlodipine

rosuvastatin group

Experimental group

Description:

Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days

Treatment:

Drug: Rosuvastatin

Drug: Amlodipine