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Completed

NCT Number: NCT03715101

A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly

A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin

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Key information

Conditions

Elderly

Age range

65 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Subjects aged 65 - 85 years
  • A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m2.
  • Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion criteria

  • Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
  • Subject judged not eligible for study participation by investigator

Treatment and study plan

Rosuvastatin

Drug

Open-label, one-sequence, multiple administration

Other names: Rosuvastatin 20 mg

Primary outcomes

  1. Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin

    Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour

    Pharmacokinetic evaluation

  2. Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin

    Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour

    Pharmacokinetic evaluation

  3. Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin

    Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour

    Pharmacokinetic evaluation

Secondary outcomes

  1. lipid panel (low-density lipoprotein cholesterol in mg/dL)

    Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

    Pharmacodynamic evaluation

  2. lipid panel (high-density lipoprotein cholesterol in mg/dL)

    Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

    Pharmacodynamic evaluation

  3. lipid panel (Triglyceride in mg/dL)

    Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

    Pharmacodynamic evaluation

  4. lipid panel (Total cholesterol in units of mg/dL)

    Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour

    Pharmacodynamic evaluation

  5. lipid metabolites

    Time frame: Day -1 0 hour, Day 21 0 hour

    Metabolites evaluation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2018
Registry last updated
Oct 22, 2018

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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