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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 is a Phase 1 study that has completed, run by American Regent. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01365624
The ClinicalTrials.gov registry entry for NCT01365624 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 American Regent, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketorolac tromethamine is the first listed.
NCT01365624 reports 0 study locations.
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.
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