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Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02079506
Enrollment
40
Registered
2014-03-05
Start date
2014-02-28
Completion date
2014-02-28
Last updated
2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGCandesartan
DRUGRosuvastatin

Sponsors

Alvogen Korea
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AUCτ,ss of rosuvastatin28 points0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
AUCτ,ss of candesartan22 points0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmax,ss of candesartan22 points0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmax,ss of rosuvastatin28 points0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

Secondary

MeasureTime frameDescription
CLss/F of rosuvastatin28 points0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
tmax,ss of candesartan22 points0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmin,ss of rosuvastatin28 points0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
CLss/F of candesartan22 points0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmin,ss of candesartan22 points0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
tmax,ss of rosuvastatin28 points0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026