Trials / Completed
CompletedNCT01607086
Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo
A Randomised, Double-blind Study in Healthy Volunteers to Compare the Properties and Characteristics of an Investigational Formulation of Lamotrigine With Placebo
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The objective of this sensory analysis study is to determine whether volunteers observe a significant difference in organoleptic properties between lamotrigine (430C78) cherry flavoured orally disintegrating tablets (ODT) and a placebo cherry flavoured orally disintegrating tablet. The aim is to assess the value of the placebo as a marketing aid, whereby physicians and patients may assess the personal acceptability of the organoleptic properties and potential convenience prior to prescription of the ODT formulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cherry lamotrigine ODT | 25mg, taken orally on one study visit |
| DRUG | Cherry Placebo | Taken orally on one study visit |
Timeline
- Start date
- 2008-07-11
- Primary completion
- 2008-07-18
- Completion
- 2008-07-18
- First posted
- 2012-05-28
- Last updated
- 2017-08-03
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01607086. Inclusion in this directory is not an endorsement.