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Evaluate Bioequivalence of Burotam (1/1 g/Vial)

NCT05654090 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-02-01

No results posted yet for this study

Summary

A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g sulbactam sodium in healthy volunteers under fasting conditions

Conditions

Interventions

DRUG

cefoperazone sodium and sulbactam sodium

Pharmacokinetic study under fasting conditions

Sponsors & Collaborators

  • Yung Shin Pharm. Ind. Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
20 Years
Sex
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-25
Primary Completion
2022-11-18
Completion
2023-02-20

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT05654090 on ClinicalTrials.gov