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.
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following
criteria apply:
- Healthy as judged by the responsible physician or designee. No clinically significant
abnormality identified on the medical or laboratory evaluation. A subject with a
clinical abnormality or laboratory parameters outside the reference range for this
age group may be included only if the Investigator and the Medical Monitor considers
that the finding will not introduce additional risk factors and will not interfere
with the study procedures.
- Volunteer must have a normal sense of taste and smell
- Non-smokers or ex-smokers who have given up smoking for at least 3 months. Subjects
currently using oral nicotine replacement therapy will not be recruited for this
study.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following
criteria apply:
- Currently being treated for epilepsy or bipolar disorder
- History of allergic, anaphylactic, hypersensitivity or idiosyncratic reaction(s) to
lamotrigine or drugs of a similar type.
- History of sensitivity to any of the following excipients- Mannitol, Crospovidone,
Sucralose, Magnesium Stearate, artificial Cherry flavour, Ethylcellulose.
- History of clinically relevant skin rashes.
- History or presence of any medical disorder which in the view of the investigator and
GSK Medical Monitor makes the subject unsuitable for the study.
- History of multiple allergies to drugs, chemicals or foods, or a history of a
clinically important allergy (e. g. anaphylaxis) to any one substance.
- Currently suffering from perennial rhinitis or seasonal rhinitis, a cold, influenza
or any other respiratory illness.
- Has received prescribed or non prescribed medication (including vitamins and herbal
remedies) within 7 days prior to the test day which in the opinion of the
investigator in consultation if necessary with the GSK Medical Monitor may interfere
with the study procedure or compromise safety.
- Currently or recently prescribed any medication which may be affected by lamotrigine
including antiepileptics.
- Participation in another sensory analysis study within 30 days preceding the test
day.
- Treatment with an investigational drug within 30 days preceding the test day.
- Females with a positive hCG pregnancy test on the test day.
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an
average daily intake of greater than 3 units for men and a weekly intake of greater
than14 units or an average daily intake of greater than 2 units for women. [NOTE: 1
unit is equivalent to a half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1
glass (125mL) of wine]. Subjects must be willing to abstain from alcohol for 24 hours
before each visit to the unit for the duration of the study.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- The subject has a positive drug/alcohol screen on the test day. A minimum list of
drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates,
cannabinoids and benzodiazepines.