Last updated: 11/07/2018 18:56:33
A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and oxcarbazepine in healthy, non-smoking, male volunteers.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
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 oxcarbazepine in healthy, non-smoking, male volunteers.
Trial description: A randomised, partially blinded, parallel group study to investigate the potential pharmacokinetic interaction between lamotrigine and oxcarbazepine 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:
Absence of pharmacokinetic drug interactions between lamotrigine and oxcarbazepine in healthy volunteers. Palmer JE;Sidhu J;Ascher JA;Job S;Theis JGW.Eur. J. Neurol. 2004;11 SUPPL. 2:76 Abs No P1157
Ascher J, Theis J, Sidhu J, et. al. Pharmacokinetics of Lamotrigine and Oxcarbazepine Co-Therapy, presented at the American Psychiatric Association Annual Meeting, May 1-6, 2004, New York, New York
Ascher JA;Theis J;Sidhu J;Job S;Palmer J.Pharmacokinetics of lamotrigine and oxcarbazepine cotherapyAm. Psychiatr. Assoc. 2004 Annu. Meet. New Res. Abstr. 2004;154-155 Abs No NR414
Ascher JA;Theis JGW;Sidhu J;Job S;Palmer J. Absence of pharmacokinetic drug interactions between lamotrigine and oxcarbazepine in healthy volunteers. Neurology 2004;62(7 SUPPL. 5):A316 Abs No P04.102.
Evoniuk G;Sidhu J;Ashcer J;Job S;Theis J. Pharmacokinetics of lamotrigine and oxcarbazepine co-therapy Int. J. Neuropsychopharmacol. 2004;7 SUPPL. 1:S154 Abs No P01.078
Evoniuk GE;Ascher J;Theis J;Sidhu J;Job S;Palmer J Pharmacokinetics of lamotrigine and oxcarbazepine co-therapy. EUR. NEUROPSYCHOPHARMACOL. 2004;14 SUPPL. 3:S210 Abs No P.1.084
Sidhu J;Ascher JA;Job S;Palmer J. Absence of pharmacokinetic drug interactions between lamotrigine and oxcarbazepine in healthy volunteers. Epilepsia 2004;45 SUPPL. 3:82 Abs No 110.
Theis JG;Sidhu J;Job S;Palmer JE;Ratcliffe JM;Ascher JA. Pharmacokinetics and tolerability of the combination of lamotrigine (LTG) and oxcarbazepine (OXC) in healthy volunteers. Clin. Pharmacol. Ther. 2004;75(2):P22 Abs No PI-72.
Theis JGW, Sidhu J, Palmer J, Job S, Bullman, J Ascher. Lack of Pharmacokinetic Interaction Between Oxcarbazepine and Lamotrigine. Neuropsychoparmacology [online]. 2005. Available at http://www.acnp.org/citations/NPP062005050071/default.pdf. Accessed July 6, 2005.
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
N/A to April 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
2003-16-04
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website