Mental DisordersPhase 1NCT00449774
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
A Phase 1 study testing Lamotrigine IR tablets and Lamotrigine ODT tablets in people with Mental Disorders, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Lamotrigine IR tablets and Lamotrigine ODT tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2007to 19 Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 19 to 55 years inclusive
- BMI within the range 19 to 32 kg/m2 inclusive.
Who cannot join
- Female subjects of childbearing potential will not be eligible 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 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 > 7 drinks week for women and 14 drinks week for men
- Current smokers of 10 or more cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Conditions
- Mental Disorders
- Being tested
- Lamotrigine IR tablets, Lamotrigine ODT tablets
- Keywords
- Food effect, Safety, Tolerability, Water effect, Bioequivalence
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine IR tabletsDrug
Also called Lamotrigine
Lamotrigine IR tablets will be available in dose strength of 200 mg.
Lamotrigine ODT tabletsDrug
Lamotrigine ODT tablets will be available in dose strength of 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Subjects in Treatment regimen C | Experimental | Subjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition. Receives: Drug: Lamotrigine ODT tablets |
| Subjects in Treatment regimen D | Experimental | Subjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition. Receives: Drug: Lamotrigine IR tablets |
| Subjects in Treatment regimen E | Experimental | Subjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state. Receives: Drug: Lamotrigine ODT tablets |
| Subjects in Treatment regimen F | Experimental | Subjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition. Receives: Drug: Lamotrigine ODT tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Measured: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Secondary outcomes (1)
Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.
Measured: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study start7 May 2007
- Primary completion19 Jun 2007
- Study completion19 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449774
- Sponsor's protocol ID
- LBI108617
- Status last verified
- Aug 2017
- First submitted
- 19 Mar 2007
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
This study has not been published in the scientific literature.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Single-dose, Parallel-group Study to Demonstrate Bioequivalence of Two Formulations and the Effect of Food and Water on One Formulation of Lamotrigine in Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT00449774
- Acronym / sponsor ID
- LBI108617
- Conditions
- Mental Disorders
- Keywords
- Food effect, Safety, Tolerability, Water effect, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 May 2007 (actual)
- Primary completion
- 19 Jun 2007 (actual)
- Study completion
- 19 Jun 2007 (actual)
- First posted
- 21 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects in Treatment regimen C | Experimental | Drug: Lamotrigine ODT tabletsSubjects in treatment regimen C will receive 200 milligram (mg) orally disintegrating tablets (ODT) of lamotrigine disintegrate in mouth without water in fasting condition. |
| Subjects in Treatment regimen D | Experimental | Drug: Lamotrigine IR tabletsSubjects in treatment regimen D will receive 200 mg Immediate Release (IR) tablets of lamotrigine with water in fasting condition. |
| Subjects in Treatment regimen E | Experimental | Drug: Lamotrigine ODT tabletsSubjects in treatment regimen E will receive 200 mg ODT disintegrate of lamotrigine in mouth without water in fed state. |
| Subjects in Treatment regimen F | Experimental | Drug: Lamotrigine ODT tabletsSubjects in treatment regimen F will receive 200 mg ODT of lamotrigine, that subjects will swallow with water in fasting condition. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects aged 19 to 55 years inclusive
- BMI within the range 19 to 32 kg/m2 inclusive.
Key exclusion criteria (6 listed)
- Female subjects of childbearing potential will not be eligible 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 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 > 7 drinks week for women and 14 drinks week for men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamotrigine IR tabletsAlso: LamotrigineLamotrigine IR tablets will be available in dose strength of 200 mg. | Drug | Subjects in Treatment regimen D |
| Lamotrigine ODT tabletsLamotrigine ODT tablets will be available in dose strength of 200 mg. | Drug | Subjects in Treatment regimen C, Subjects in Treatment regimen E, Subjects in Treatment regimen F |
Primary outcome
Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
Time frame: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours
1 secondary outcome
Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.
Time frame: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- BackgroundThis study has not been published in the scientific literature.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study LBI108617 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Related trials for Mental Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lamotrigine IR tablets and Lamotrigine ODT tablets in people with Mental Disorders, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours (time frame: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.