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Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

NCT04982861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-08-11

No results posted yet for this study

Summary

This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan.

Conditions

  • Drug Use

Interventions

DRUG

Cefixime Trihydrate 100 mg/5 mL Dry Syrup

Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water

DRUG

Suprax 100 MG in 5 mL Oral Suspension

Participants received a single dose of 5 mL of Suprax with 240 mL of water

Sponsors & Collaborators

  • PT Pharma Metric Labs

    collaborator INDUSTRY

  • PT Bernofarm

    lead INDUSTRY

Principal Investigators

  • I Gusti Putu Bagus Diana Virgo · PT Pharma Metric Labs, Indonesia

  • Arini Setiawati · PT Pharma Metric Labs, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2020-08-15
Completion
2020-08-25

Countries

  • Indonesia

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 NCT04982861 on ClinicalTrials.gov