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Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079506
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Candesartan Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment A Drug: Candesartan
Experimental: Treatment B Drug: Rosuvastatin



Primary Outcome Measures :
  1. AUCτ,ss of candesartan [ Time Frame: 22 points ]
    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

  2. Cmax,ss of candesartan [ Time Frame: 22 points ]
    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

  3. AUCτ,ss of rosuvastatin [ Time Frame: 28 points ]
    0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

  4. Cmax,ss of rosuvastatin [ Time Frame: 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 :
  1. tmax,ss of candesartan [ Time Frame: 22 points ]
    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

  2. CLss/F of candesartan [ Time Frame: 22 points ]
    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

  3. Cmin,ss of candesartan [ Time Frame: 22 points ]
    0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h

  4. tmax,ss of rosuvastatin [ Time Frame: 28 points ]
    0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

  5. CLss/F of rosuvastatin [ Time Frame: 28 points ]
    0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h

  6. Cmin,ss of rosuvastatin [ Time Frame: 28 points ]
    0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079506


Locations
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Korea, Republic of
Chungnam National University Hospital
Jung-gu, Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
Alvogen Korea
Investigators
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Principal Investigator: JangHee Hong, PhD. Chungnam National University Hospital

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Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT02079506    
Other Study ID Numbers: DP-CTR208-I-01
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Candesartan
Candesartan cilexetil
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists