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NCT00828568 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Two Imiquimod Cream 5%
A Phase 1 study, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Phase 1
- Development phase
- 425
- Enrollment target
NCT00828568 is a Phase 1 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 425 participants.
The verdict
NCT00828568, a Phase 1 study, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 425 participants
- Enrollment target
Study Summary
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams.
Interventions
- DRUG Imiquimod 5% manufactured by Taro
- DRUG Aldara - Imiquimod 5%
- DRUG Imiquimod Vehicle manufactured by Taro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00828568
The ClinicalTrials.gov registry entry for NCT00828568 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Imiquimod 5% manufactured by Taro is the first listed.
NCT00828568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00828568 about?
NCT00828568 is a clinical study titled "Bioequivalence Study of Two Imiquimod Cream 5%". The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event...
What is the current status of trial NCT00828568?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 425 participants. The study started on 2008-06. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00828568?
The interventions under investigation include: Imiquimod 5% manufactured by Taro (DRUG), Aldara - Imiquimod 5% (DRUG), Imiquimod Vehicle manufactured by Taro (DRUG).
Who is sponsoring clinical trial NCT00828568?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
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