Clinical Trial to Compare the Pharmacokinetics of DP-R208

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rosuvastatin; Drug: Candesartan cilexetil; Drug: DP-R208

Study type: Interventional

Funder types: Industry

Identifiers

NCT02707224

DP-CTR208-I-02

Details and patient eligibility

About

A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers

Enrollment: 40 patients

Sex: Male

Ages: 19 to 55 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 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: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A

Experimental group

Description:

combination dose of Candesartan cilexetil and Rosuvastatin and DP-R208 in order

Treatment:

Drug: Candesartan cilexetil

Drug: Rosuvastatin

Drug: DP-R208

Group B

Experimental group

Description:

DP-R208 and combination dose of Candesartan cilexetil and Rosuvastatin in order

Treatment:

Drug: Candesartan cilexetil

Drug: Rosuvastatin

Drug: DP-R208