Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin
Information source: DreamPharma
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Candesartan (Drug); Rosuvastatin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: DreamPharma Official(s) and/or principal investigator(s): JangHee Hong, PhD., Principal Investigator, Affiliation: Chungnam National University Hospital
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUCτ,ss of candesartanCmax,ss of candesartan AUCτ,ss of rosuvastatin Cmax,ss of rosuvastatin
Secondary outcome: tmax,ss of candesartanCLss/F of candesartan Cmin,ss of candesartan tmax,ss of rosuvastatin CLss/F of rosuvastatin Cmin,ss of rosuvastatin
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Chungnam National University Hospital, Jung-gu, Daejeon 301-721, Korea, Republic of
Additional Information
Starting date: February 2014
Last updated: March 4, 2014
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