Last updated: 11/04/2018 08:37:56
Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A pivotal single-dose randomised, parallel-group, open-label study to demonstrate bioequivalence of 300mg lamotrigine XR relative to 100mg + 200mg lamotrigine XR and to demonstrate lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers
Trial description: This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
pharmacokinetics ie Serum lamotrigine Cmax and AUC(0-inf)
Timeframe: taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing
Secondary outcomes:
PK (AUC (0-t), tmax and t1/2 )
Timeframe: taken pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26, 36, 48, 72, 96, 120 and 144 hours following dosing
safety and tolerability based on physical exam, adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate measure
Timeframe: at Screening, Day -1, Day 1, Day 2 and follow up 7-14 days after dosing
Interventions:
Enrollment:
180
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
February 2007 to April 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 – 29.9 kg/m2 inclusive.
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest.
- Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
Inclusion and exclusion criteria
Inclusion criteria:
- Body weight >50 kg (males) or >45 kg (females) and BMI within the range 19 – 29.9 kg/m2 inclusive.
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
Exclusion criteria:
- Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest.
- Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
- Female subjects using hormonal contraceptive precautions including progesterone-coated IUD
- Female subjects using hormonal replacement therapy.
- Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed).
- Current smokers of 10 or more cigarettes per day.
Trial location(s)
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-27-04
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
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Additional information
Results for study LAM105379 can be found on the GSK Clinical Study Register.
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