Study to Compare Two Formulations of Lamotrigine in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 19 - 55 |
| Updated: | 9/13/2017 |
| Start Date: | December 28, 2006 |
| End Date: | January 25, 2007 |
An Open-label, Randomised, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Characteristics, Safety and Tolerability of up to Two Formulations (With Different Taste Masking Approaches) of an Orally Disintegrating Tablet (ODT) of Lamotrigine at 25mg and 200mg Versus the Immediate Release (IR) Lamotrigine in Healthy Subjects
This study intends to compare the pharmacokinetic characteristics, safety and tolerability of
two formulations of lamotrigine in healthy male and female volunteers
two formulations of lamotrigine in healthy male and female volunteers
Inclusion Criteria:
- Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 to 30 kg/m2
inclusive.
Exclusion Criteria:
- Female subjects of childbearing potential will not be eligible to participate if they
are unwilling or unable to use an appropriate method of contraception at least 30 days
prior to the first study drug through 30 days.
- Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at
Screening and pre-dose to the study) or lactating.
- Female subjects using hormonal contraceptive precautions including progesterone-coated
intra-uterine device (IUD).
- Female subjects using hormonal replacement therapy.
- History of regular alcohol consumption
- Current smokers of 10 or more cigarettes per day
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