NCT01322464

Study to Assess Food Effect on Sativex Bioavailability

A Phase I Study to Assess the Effect of Food on the Single-Dose Bioavailability of Sativex, and to Compare the Single and Multiple Dose Pharmacokinetics of Sativex at Three Dose Levels

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study to assess effect of food on the bioavailability of a single dose of Sativex and to measure its' pharmacokinetics after a single and multiple doses.

Detailed description

This was an open-label, randomised, ascending dose, 2-way crossover food-effect study incorporating a parallel single and multiple dose components in healthy subjects.

Conditions

• Food Effect

Interventions

Type	Name	Description
DRUG	Sativex	4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
DRUG	Sativex	4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
DRUG	Sativex	2 sprays Sativex daily in fasted state Days 4-13.
DRUG	Sativex	8 sprays Sativex daily in fasted state Days 4-13.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2011-03-24
• Last updated: 2023-04-10

Locations

1 site across 1 country: United Kingdom