Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Candesartan; Drug: Rosuvastatin

• Registration Number: NCT02079506
• Lead Sponsor: Alvogen Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Last Update Submitted: 2014-03-04
• Study First Posted: 2014-03-05
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Candesartan	-
Treatment B	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
AUCτ,ss of candesartan	22 points	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmax,ss of candesartan	22 points	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
AUCτ,ss of rosuvastatin	28 points	0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Cmax,ss of rosuvastatin	28 points	0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

Secondary Outcome Measures

Name	Time	Method
CLss/F of candesartan	22 points	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
tmax,ss of rosuvastatin	28 points	0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
CLss/F of rosuvastatin	28 points	0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
tmax,ss of candesartan	22 points	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmin,ss of candesartan	22 points	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmin,ss of rosuvastatin	28 points	0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Jung-gu, Daejeon, Korea, Republic of