Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules
Status:
Completed
Trial end date:
2017-03-06
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Tillotts Pharma AG
Collaborators:
SocraTec R&D GmbH Swiss Commission for Technology and Innovation University Hospital, Basel, Switzerland University of Basel