drugset / Trial / NCT02911298
Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules
Phase 1
Completed
18 enrolled
Tillotts Pharma AG
SocraTec R&D GmbH · collabSwiss Commission for Technology and Innovation · collabUniversity Hospital, Basel, Switzerland · collabUniversity of Basel · collab
Non-randomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2016-11-25
- Primary completion
- 2017-03-06
- Completion
- 2017-03-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metronidazole Benzoate | Small molecule | 100 mg | — |
Indications
No indication recorded.