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Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.

NCT02146209 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-08-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether Terix Labs Ltd Metronidazole benzoate (400 mg Metronidazole Per Sachet Oral Granules) is bioequivalent to 500 mg Sanofi-aventis Flagyl 125 mg/5 ml (125 mg Metronidazole Per 5 ml Suspension) and to Zentiva Flagyl™ 400 mg Tablets (400 mg Metronidazole Per Film Coated Tablets).

Conditions

Interventions

DRUG

Metronidazole benzoate

Single oral dose of 400 mg

DRUG

Flagyl 125 mg/5 ml oral suspension

Single oral dose of 500 mg (20 ml suspension)

DRUG

Flagyl 400 mg Tablets

Single oral dose of 400 mg

Sponsors & Collaborators

  • Verisfield UK Ltd. Greek Branch

    lead INDUSTRY

Principal Investigators

  • Naji Najib, B.Sc. Pharm · IPRC Jordan

  • Abdullah Hiyari, MD · IPRC Jordan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Jordan

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 NCT02146209 on ClinicalTrials.gov