NCT02911298

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

An Open Label, Single-site Pharmaco-Scintigraphic Phase I - Study in Healthy Subjects to Evaluate the Gastrointestinal Transit and Release Profile of Radio-labelled Metronidazole Benzoate Capsules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Tillotts Pharma AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation
DRUG	Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation

Timeline

• Start date: 2016-11-25
• Primary completion: 2017-03-06
• Completion: 2017-03-06
• First posted: 2016-09-22
• Last updated: 2017-04-04

Locations

1 site across 1 country: Switzerland