Last updated: 11/07/2018 19:47:49
Seven day administration of BW 430C (LAMICTAL) to normal volunteers- multiple dose pharmacokinetics and safety.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Seven day administration of BW 430C (LAMICTAL) to normal volunteers- multiple dose pharmacokinetics and safety.
Trial description: Seven day administration of BW 430C (LAMICTAL) to normal volunteers- multiple dose pharmacokinetics and safety.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Binnie CD. Lamotrigine. Comprehensive Epileptology. New York Raven Press 1990:665-670.
Cohen AF, Ashby L, Crowley D, Peck AW. Pharmacokinetics in normal man of lamotrigine (BW430C), a new anticonvulsant. Proceedings of the BPS 1985 Apr 10-12. British Journal of Clinical Pharmacology 1985; 20(3); 286
Cohen AF, Fowle ASE, Land GS and Bye A. BW430C: a new anticonvulsant, pharmacokinetics in normal man. Proceedings of the American Epilepsy Society Meeting; 1984 Nov 8-9; San Francisco (CA). Epilepsia 1984;25(5):656.
Cohen AF, Land GS, Breimer DD, Yuen WC et al. Lamotrigine, a new anticonvulsant: Pharmacokinetics in normal humans. Clin Pharmacol Ther 1987;42:535-41.
Miller AA, Sawyer DA, Roth B, Peck AW et al. Lamotrigine. New Anticonvulsant Drugs 1986; 165-177.
Porter RJ. Antiepileptic drug development: clinical studies of new chemical entities. Advances in Epileptiology;16:523-530.
Prous JR. Lamotrigine. Drugs Future 1986;11(6)456-459.
Medical condition
Depressive Disorder, Major
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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