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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01322464
Other study ID # GWCP0601
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 2008
Est. completion date February 2008

Study information

Verified date April 2023
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
Sativex
2 sprays Sativex daily in fasted state Days 4-13.
Sativex
8 sprays Sativex daily in fasted state Days 4-13.

Locations

Country Name City State
United Kingdom Guy's Drug Research Unit, Quintiles Ltd. London

Sponsors (1)

Lead Sponsor Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Stott CG, White L, Wright S, Wilbraham D, Guy GW. A phase I study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray. Eur J Clin Pharmacol. 2013 Apr;69(4):825-34. doi: 10.1007/s00228-012-1393-4. Epub 2012 Oct 4 — View Citation

Stott CG, White L, Wright S, Wilbraham D, Guy GW. A phase I study to assess the single and multiple dose pharmacokinetics of THC/CBD oromucosal spray. Eur J Clin Pharmacol. 2013 May;69(5):1135-47. doi: 10.1007/s00228-012-1441-0. Epub 2012 Nov 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary PK Endpoints Cmax, AUC(0-inf), T-half and CL/F: under fasting conditions (Group 1, Day 1 and 4 fasted data) and under fed conditions (Group 1 Day 1 and 4 fed data)
Secondary Secondary PK measures Cmax, Tmax, AUC(0-t), t-half, CL/F, Varea/F from Day 4 (Groups 2 and 3) and from fasted subjects on days 1 and 4 (Group 1) Cmax, Cmin, Tmax, AUC(0-t), Flux from Day 12 data (all groups)
Secondary Safety and tolerability of Sativex
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