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Completed

NCT Number: NCT05681247

Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Center

Qingdao, Shandong, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female subjects ≥18 years of age
  • The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).
  • The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
  • Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).

Exclusion criteria

  • any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases
  • hepatic/renal impairment
  • abnormal vital signs
  • drug or alcohol abuse
  • smoking ≥5 cigarettes per day ,
  • donation(≥300ml) o
  • enrollment in other clinical trials during the 3 months prior to screening
  • allergic to ezetimibe or its excipients
  • any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
  • lactating or pregnant women

Treatment and study plan

ezetimibe tablet

Drug

The subjects randomly received single oral administration of ezetimibe tablet 10 mg

ezetimibe tablet(Ezetrol ®)

Drug

The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.

Primary outcomes

  1. Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)

    Time frame: 80 days

    Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC)0-t

    Time frame: 80 days

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2023
Registry last updated
Jan 12, 2023

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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