Trials / Completed
CompletedNCT03271983
Pharmacokinetics of Metronidazole Dermal Products
Evaluation of the Bioavailability of Metronidazole Dermal Products
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Generate human PK data by collecting data following the application of metronidazole formulations.
Detailed description
This research study is intended to develop models for in vitro/in vivo correlation (IVIVC) of drug absorption from dermal products. This study will use metronidazole products that have already been approved by the Food and Drug Administration (FDA) and are already sold to customers in the United States; will not include any placebos.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metronidazole gel 1 | RLD gel |
| DRUG | Metronidazole gel 2 | generic gel |
| DRUG | Metronidazole cream | generic cream |
Timeline
- Start date
- 2019-04-09
- Primary completion
- 2019-10-31
- Completion
- 2019-11-03
- First posted
- 2017-09-05
- Last updated
- 2022-05-17
- Results posted
- 2022-05-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03271983. Inclusion in this directory is not an endorsement.