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Completed

NCT Number: NCT02079506

Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam National University Hospital

Jung-gu, Daejeon, 301-721, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan

Drug

Rosuvastatin

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alvogen Korea

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2014
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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