Last updated: 11/07/2018 18:56:19
A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and olanzapine in healthy, non-smoking, male volunteers.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and olanzapine in healthy, non-smoking, male volunteers.
Trial description: A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and olanzapine in healthy, non-smoking, male volunteers.
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:
Abstract: A bi - directional pharmacokinetic interaction and tolerability study of lamotrigine and olanzapine co - administration in healthy volunteers. Sidhu, J. 1, Job, S. 1, Ratcliffe, J. 1, Ascher, J. 1, Metz, A. 1, Lieberman, J. 2, and Theis, J. 1 42nd Annual Meeting of the American College of Neuropsychopharmacology 12/7/2003 Puerto Rico
Abstract: A pharmacokinetic interaction study of lamotrigine and olanzapine co-administration. Ascher, John MD, Theis, Jochen PhD, Sidhu, Jagdev PhD, Job, Sarah PhD, and Palmer, Joanne PhD 17th Annual U.S. Psychiatric and Mental Health Congress 11/18/2004 San Diego, CA; USA
Abstract: A pharmacokinetic interaction study of lamotrigine and olanzapine. Ascher, John A. M. D., Sidhu, Jagdev Ph. D., Job, Sarah M. S. C., and Theis, Jochen M. D. 157th Annual Meeting of the American Psychiatric Association 5/1/2004 New York, NY; USA
Abstract: A pharmacokinetic interaction study of lamotrigine and olanzapine. Ascher, John M. D., Sidhu, Jagdev Ph. D., Job, Sarah M. Sc., and Theis, Jochen Ph. D 44th Annual New Clinical Drug Evaluation Unit (NCDEU) Meeting 6/1/2004 Phoenix, AZ; USA
Abstract: A pharmacokinetic interaction study of lamotrigine and olanzapine. Evoniuk, G. E., Ascher, J., Sidhu, J., Job, S., and Theis, J. 17th Congress of the European College of Neuropsychopharmacology (ECNP) 10/9/2004 Stockholm; Sweden
Abstract: Pharmacokinetic interaction and tolerability of lamotrigine and olanzapine co-administration in healthy volunteers. Evoniuk, Gary, Sidhu, Jagdev, Job, Sarah, Ascher, John, and Theis, Jochen International Congress of the World Federation of Biological Psychiatry 2/9/2004 Sydney; Australia
Ascher J, Sidhu J, Job S, et. al. A Pharmacokinetic Interaction Study of Lamotrigine and Olanzapine, presented at the American Psychaitric Association annual Meeting, May 1- 6, 2004, New York, New York
Evoniuk G;Sidhu J;Ashcer J;Job S;Theis J.A pharmacokinetic interaction study of lamotrigine and olanzapine.Int. J. Neuropsychopharmacol. 2004;7 SUPPL. 1:S323 Abs No P02.066.
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
September 2002 to March 2003
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
Clinical study report
Available language(s): English
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
2003-27-03
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
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