Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01202799 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
A Phase 1 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01202799 is a Phase 1 study that has completed, run by Mallinckrodt. The registered enrollment target is 30 participants.
The verdict
NCT01202799, a Phase 1 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).
Interventions
- DRUG 2% w/w diclofenac sodium topical gel
- DRUG 1.5% w/w diclofenac sodium topical solution
- DRUG 75 mg diclofenac sodium delayed release tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-09 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01202799
The ClinicalTrials.gov registry entry for NCT01202799 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 2% w/w diclofenac sodium topical gel is the first listed.
NCT01202799 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01202799 about?
NCT01202799 is a clinical study titled "Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel". It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved ...
What is the current status of trial NCT01202799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-09. Estimated completion is 2010-11.
What interventions are being tested in trial NCT01202799?
The interventions under investigation include: 2% w/w diclofenac sodium topical gel (DRUG), 1.5% w/w diclofenac sodium topical solution (DRUG), 75 mg diclofenac sodium delayed release tablet (DRUG).
Who is sponsoring clinical trial NCT01202799?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.