NCT03245918

Relative Bioavailability of an Extemporaneous Oral Suspension of Aprepitant in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Antiemetic therapies have improved in recent years, but chemotherapy-induced nausea and vomiting (CINV) are still common and are among the most distressing side effects of chemotherapy. Aprepitant is commercially available in Canada as capsules. An oral liquid aprepitant formulation would be ideal for oral administration to patients unable to swallow capsules.

Conditions

• Chemotherapy-induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Aprepitant Capsule 125 MG	Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
DRUG	Aprepitant oral suspension 20 mg/mL	Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period

Timeline

• Start date: 2017-08-10
• Primary completion: 2017-12-31
• Completion: 2018-01-05
• First posted: 2017-08-10
• Last updated: 2022-04-11

Locations

1 site across 1 country: Canada