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

2016-09-22 20:53:28 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Healthy

Intervention

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

Location

University Hospital Basel, Phase I Research Unit
Basel
Basel-Stadt
Switzerland
4031

Status

Not yet recruiting

Source

Tillotts Pharma AG

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-22T20:53:28-0400

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