DP-R208 Pharmacokinetic Study

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709187

DP-CTR208-I-04

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-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Enrollment: 37 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 18~30
• 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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37 participants in 2 patient groups

RT group

Experimental group

Description:

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

Treatment:

Drug: Candesartan cilexetil

Drug: DP-R208

Drug: Rosuvastatin

TR group

Experimental group

Description:

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

Treatment:

Drug: Candesartan cilexetil

Drug: DP-R208

Drug: Rosuvastatin