DP-R212 Pharmacokinetic Study Phase I

Alvogen

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: DP-R212; Drug: Amlodipine; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02814500

DP-CTR-212-I-02

Details and patient eligibility

About

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

Full description

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Enrollment: 36 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 17.5~30.5
• 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 30 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: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

A group

Experimental group

Description:

Amlodipine and Rosuvastatin, DP-R212

Treatment:

Drug: DP-R212

Drug: Amlodipine

Drug: Rosuvastatin

B group

Experimental group

Description:

DP-R212, Amlodipine and Rosuvastatin

Treatment:

Drug: DP-R212

Drug: Amlodipine

Drug: Rosuvastatin