Phase 1
Completed N=42
A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165)
Source: ClinicalTrials.gov NCT00945321 ↗Enrolled (actual)
42
Serious AEs
0.6%
Results posted
Jun 2010
Primary outcomePrimary: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg — 34589; 39053; 37375; 37795 ng•hr/mL — p=0.001
Summary
This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on the bioavailability of oral aprepitant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg |
34589; 39053; 37375; 37795; 50172; 51146 | 0.001 sig |
| PRIMARY Peak Plasma Concentration (Cmax) Following Single Dose Administration of Aprepitant 165 mg or 185 mg and Fosaprepitant 150 mg. |
1738; 1636; 1870; 2362; 2116; 1995 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is in good health
- Subject is a nonsmoker
- Subject is willing to comply with the study restrictions
Exclusion Criteria
- Subject has a history of any illness that might confound the results of the study or might make participation in the study unsafe
- Subject has a history of stroke, seizures, or major neurological disorder
- Subject has a history of cancer
- Subject consumes more than two alcoholic drinks per day
- Subject consumes more than three caffeinated beverages daily
Data sourced from ClinicalTrials.gov (NCT00945321). 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.