Phase 1
Completed N=30
Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
Healthy Subjects
Source: ClinicalTrials.gov NCT01365624 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Cmax (Maximum Plasma Concentration) — 1782.286; 1840.111 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximum Plasma Concentration) |
1782.286; 1840.111 | — |
| PRIMARY Tmax (Time to Reach Maximum Plasma Concentration) |
0.750; 0.750 | — |
| PRIMARY AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose |
7323.5; 6536.5 | — |
| PRIMARY AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity |
8794.8; 6890.8 | — |
| PRIMARY t1/2z (Terminal Half-life) |
4.521; 3.313 | — |
| PRIMARY MRT (Mean Residence Time) |
6.024; 4.441 | — |
Eligibility Criteria
Inclusion Criteria
- The elderly population consisted of male or female volunteers aged > of = 65 years
- The nonelderly adult population consisted of male or female volunteers aged 2.0 mg/dL
- Current tobacco use or a past history of smoking within 5 years of study entry
- Any other clinically significant medical problem, which in the opinion of the Investigator would interfere with study participation
- Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study.
Data sourced from ClinicalTrials.gov (NCT01365624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.