Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss Commission for Technology and Innovation | OTHER |
| University of Basel | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
| SocraTec R&D GmbH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucoadhesive formulation | Experimental | A single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation is administered to subject in fasted state |
|
| Non-mucoadhesive formulation | Active Comparator | A single dose of 100 mg Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation is administered to subject in fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation | Drug |
| ||
| Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Scintigraphic analysis of time of capsule disintegration | 3 days | |
| Scintigraphic analysis of location of capsule disintegration | 3 days | |
| Transit time of the released granules after capsule disintegration | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal plasma concentration (Cmax) | 3 days | |
| Time to reach Cmax (Tmax) | 3 days | |
| Area under the concentration-time curve |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manuel Haschke, MD | University Hospital Basel, Phase I Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Phase I Research Unit | Basel | Canton of Basel-City | 4031 | Switzerland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 3 days |
| Elimination rate constant (k) | 3 days |
| Apparent terminal half-live (t½) | 3 days |
| Lag time (t-lag) | 3 days |
| Time of first measurable concentration after dosing | 3 days |