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NCT01365624 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
A Phase 1 study, sponsored by American Regent.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01365624: Completed Phase 1 study, sponsored by American Regent.
NCT01365624 is a Phase 1 study that has completed, run by American Regent. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01365624, a Phase 1 study, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.
Interventions
- DRUG Ketorolac tromethamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
What the finished NCT01365624 record still lists
NCT01365624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Ketorolac tromethamine is the first listed.
NCT01365624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01365624 about?
NCT01365624 is a clinical study titled "Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects". This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. The primary objective of this trial was to ...
What is the current status of trial NCT01365624?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-02. Estimated completion is 2008-07.
What interventions are being tested in trial NCT01365624?
The interventions under investigation include: Ketorolac tromethamine (DRUG).
Who is sponsoring clinical trial NCT01365624?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01365624's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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