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Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules

NCT02911298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-04-04

No results posted yet for this study

Summary

This is a Phase I, open label, single-site trial to evaluate the in vivo release characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to disintegrate in the large intestine. This will be examined by means of metronidazole plasma levels and scintigraphic images in healthy subjects. Overall, nine subjects will be evaluated for each formulation prototype. Two formulation prototypes will be investigated. Each subject will receive one radio-labelled capsule only.

Conditions

  • Healthy

Interventions

DRUG

Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation

DRUG

Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation

Sponsors & Collaborators

  • Swiss Commission for Technology and Innovation

    collaborator OTHER

  • University of Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • SocraTec R&D GmbH

    collaborator OTHER

  • Tillotts Pharma AG

    lead INDUSTRY

Principal Investigators

  • Manuel Haschke, MD · University Hospital Basel, Phase I Research Unit

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-25
Primary Completion
2017-03-06
Completion
2017-03-06

Countries

  • Switzerland

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 NCT02911298 on ClinicalTrials.gov