Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Candesartan; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079506

DP-CTR208-I-01

Details and patient eligibility

About

The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers af aged between 20 years to 45 years
• Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
• Eligible subjects with acceptable medical history and physical examination

Exclusion criteria

• Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment A

Experimental group

Treatment:

Drug: Candesartan

Treatment B

Experimental group

Treatment:

Drug: Rosuvastatin