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Study to Assess Food Effect on Sativex Bioavailability

NCT01322464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-04-10

No results posted yet for this study

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.

Conditions

  • Food Effect

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322464 on ClinicalTrials.gov