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Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate

NCT02402283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-06-23

No results posted yet for this study

Summary

The purpose of this study is to determine the bioequivalence of Metronidazole benzoate (400 mg metronidazole per sachet oral granules)/Terix Labs Ltd and Flagyl™ 400 mg Tablets (400 mg metronidazole per film coated tablet)/Zentiva.

Conditions

  • Healthy

Interventions

DRUG

Metronidazole benzoate oral granules

Single oral dose of 400 mg

DRUG

Flagyl 400 mg Tablets

Single oral dose of 400 mg

Sponsors & Collaborators

  • Verisfield UK Ltd. Greek Branch

    lead INDUSTRY

Principal Investigators

  • Naji Naji, B.Sc. Pharm · International Pharmaceutical Research Center

  • Abdullah Hiyari, M.D. · International Pharmaceutical Research Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Jordan

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 NCT02402283 on ClinicalTrials.gov