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NCT02911298
Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules
Phase 1 trial testing Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation in Healthy in 18 participants. Completed in 6 March 2017.
6 March 2017
Quick facts
| Lead sponsor | Tillotts Pharma AG |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 25 November 2016 |
| Primary completion | 6 March 2017 |
| Estimated completion | 6 March 2017 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation — full drug profile →
- Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Tillotts Pharma AG — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02911298
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02911298 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tillotts Pharma AG
- Last refreshed: 4 April 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02911298.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing