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Bioavailability of ATI-1501 With Taste Test Sub Study

NCT03337126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-01-11

No results posted yet for this study

Summary

Appili Therapeutics Inc. is developing an oral suspension formulation of metronidazole (ATI-1501), a taste-masked reformulation of metronidazole. The purpose of this study is to compare the relative bioavailability of ATI-1501 with the Reference Listed Drug (RLD) in healthy, adult volunteers to determine that it is Bioequivalent.

Conditions

  • Bioequivalence

Interventions

DRUG

Metronidazole Tablet

Comparator Drug

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Appili Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Michael McDonnell, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2017-12-13
Completion
2017-12-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT03337126 on ClinicalTrials.gov