Status Unknown

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID05381870

Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

Led by The Affiliated Hospital of Qingdao University · Updated on 2022-05-19

48

Participants Needed

N/A

Research Sites

17 weeks

Total Duration

On this page

Sponsors

T

The Affiliated Hospital of Qingdao University

Lead Sponsor

C

Changzhou Pharmaceutical Factory Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

CONDITIONS

Official Title

Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female aged 18 and above.
  • The body mass index is in the range of 18.6-28.5 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.
  • The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
  • The subjects have no family planning within 3 months and could select contraceptive method.
  • Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Not Eligible

You will not qualify if you...

  • Being allergy to the study medications, smoking, alcohol abuse.
  • Participation in another clinical trial within 3 months.

Trial Site Locations

Site Locations not provided

Location information for this trial is currently unavailable.

Research Team

X

Xin Li, Doctor

Y

Yu Cao, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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