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Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers

NCT04414254 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-04

No results posted yet for this study

Summary

An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each condition) to assess the bioequivalence between two formulations of cefprozil.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)

Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods."Cefprozil for Suspension®" (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Yu Cao, Doctor · the study director of phase I clinical research center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2018-11-22
Completion
2019-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414254 on ClinicalTrials.gov