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NCT05968482 · ClinicalTrials.gov registry record · Phase 1
Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants
A Phase 1 study, sponsored by Amzell.
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT05968482 is a Phase 1 study that has completed, run by Amzell. The registered enrollment target is 74 participants.
The verdict
NCT05968482, a Phase 1 study, has completed, sponsored by Amzell.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to compare drug exposure from two different products (AMZ001 and Diclofenac Sodium 1% Gel) in healthy participants on Day 7 after repeated topical administrations for 7 days. Participants will receive, in a crossover design, three different treatments * AMZ001 Low dose * AMZ001 High dose * Diclofenac Sodium 1% Gel Safety and tolerability of AMZ001 will be also investigated.
Interventions
- DRUG Diclofenac Sodium Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2024-12-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05968482
The ClinicalTrials.gov registry entry for NCT05968482 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amzell, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Diclofenac Sodium Gel is the first listed.
NCT05968482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05968482 about?
NCT05968482 is a clinical study titled "Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants". The goal of this clinical trial is to compare drug exposure from two different products (AMZ001 and Diclofenac Sodium 1% Gel) in healthy participants on Day 7 after repeated topical administrations for 7 days. Participants will receive, in a crossover design, three different treatments * AMZ001 Lo...
What is the current status of trial NCT05968482?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2023-07-11. Estimated completion is 2024-12-02.
What interventions are being tested in trial NCT05968482?
The interventions under investigation include: Diclofenac Sodium Gel (DRUG).
Who is sponsoring clinical trial NCT05968482?
This trial is sponsored by Amzell, which has 3 total clinical trials registered on ClinicalTrials.gov.
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