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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 candesartan

Cmax,ss of candesartan

AUCτ,ss of rosuvastatin

Cmax,ss of rosuvastatin

Secondary outcome:

tmax,ss of candesartan

CLss/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

Page last updated: August 20, 2015

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