EpilepsyPhase 1NCT01879423
The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects
A Phase 1 study testing Lamotrigine Dispersible/Chewable tablets 5mg*5 and Lamotrigine Compressed tablet 25mg in people with Epilepsy, run by GlaxoSmithKline at 1 site in China.
Trial summary
This is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lamotrigine Dispersible/Chewable tablets 5mg*5 and Lamotrigine Compressed tablet 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2013to 6 Jun 2013
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male non-smoker, based on medical history and physical examination.
- 18-40 years old, inclusive.
- Body weight >50 kg, and result of BMI is between 18.0 and 24.0 kg/m2, inclusive.
- Capable of returning to study site for follow-up according to the requirement of protocol and willing to comply with the policy, procedure and restriction of the study.
- Capable of reading and understanding the information listed in the consent form. Signing the informed consent prior to any study related procedure.
- Results of laboratory tests within the range of reference normal range, or slight abnormality which judged as not clinically significant by investigator.
Show all 11Show fewer
- AST, ALT, alkaline phosphatase and total bilirubin =<1.5 x ULN ((total bilirubin >1.5 x ULN alone is acceptable if direct bilirubin <35% of total bilirubin).
- Normal blood pressure (systolic blood pressure 90-140 mmHg, diastolic blood pressure < 90mmHg) and pulse rate (60-100/min).
- No clinically significant abnormality on 12-lead ECG.
- Corrected QT interval < 450 ms; or corrected QT interval < 480 ms for subjects with bundle-branch block.
- Male subjects with female partners of child-bearing potential must agree to use contraceptive method after first dose of study treatment and until two weeks after the completion of the study.
Who cannot join
- Current or chronic history of cardiovascular, respiratory, gastrointestinal, endocrine, hepatic, hematological, psychical or nervous system diseases, use of drug that can change the absorption, metabolism or elimination of study drug, or result in danger or other drugs or diseases that interfere with the interpretation of study data.
- Personal or familial history of hypersensitivity to lamotrigine or drug with similar chemical composition.
- Participation in other clinical trial within 30 days prior to enrollment in the study.
- Use of prescription or non-prescription drugs, including monoamine oxidase inhibitor or herbal drug within 14 days prior to the screening; excluding use of lubricating oil or contraceptive barrier device containing spermicidal agents, and other contraception device.
- History of abnormality of liver function, abnormal hepatic or biliary system, or positive hepatitis B surface antigen (HBsAg), or positive hepatitis C surface antibody (HCAb) or ALT ≥ 2x upper limit of normal (ULN). Having Gilbert syndrome.
- Positive serum HIV antibody.
Show all 13Show fewer
- Alcohol abuser, defined as alcohol consumption exceeding 3 units/day or 21 units/week. A unit equal to about 240 ml beer, 25 ml spirits or 125 ml wine.
- Positive drug monitoring at screening.
- Evidence for obviously active disease of hematological system, or obvious blood loss within 3 months.
- Blood donation 3 months prior to study.
- Current or past history of nervous-psychiatric disorder, as assessed by Columbia Suicide Severity Rating Scale-baseline evaluation or in the opinion of investigator that the subject is at risk of suicide or with history of suicide behavior/attempt.
- Unsuitable for participating in the study according to the law.
- Unsuitable for participating in the study in the opinion the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Demonstrate the Bioequivalence of Lamotrigine Dispersible/Chewable Tablets (5mg×5) and Lamotrigine Compressed Tablet (25mg) in Healthy Chinese Male Subjects.
This is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will also be assessed.
Read the detailed description
This is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. 24 healthy Chinese male subjects will be enrolled to provide data from at least 22 evaluable subjects . In Period 1, subjects will be randomized in equal numbers to be dosed with either lamotrigine dispersible/chewable 5mg×5 tablets or lamotrigine compressed tablet 25mg×1. Following a washout of at least 14 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
Pharmacokinetic blood samples will be collected over 168 hours post dose. Venous blood (2 ml each) is taken immediately before dosing (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post dose to determine the lamotrigine concentration in serum. Drug concentration in serum at different time points will be determined for each subject with a validated bioanalytical method using LC/MS/MS method. The main pharmacokinetic parameters such as Cmax, tmax, AUC(0-inf), AUC(0-t), t1/2, λz, CL/F and Vd/F are calculated for subjects using non-compartment analysis method.
Physical examination, electrocardiogram and clinical laboratory tests are conducted at screening and 168 hours after administration of each dose; vital signs are measured at scheduled time; adverse events are recorded throughout the study. Clinically relevant safety measurement values are tabulated to evaluate the safety and tolerability of lamotrigine dispersible/chewable tablet. Safety evaluation lasts up to 168 hours after the second oral administration.
- Conditions
- Epilepsy
- Being tested
- Lamotrigine Dispersible/Chewable tablets 5mg*5, Lamotrigine Compressed tablet 25mg
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine Dispersible/Chewable tablets 5mg*5Drug
Also called Lamictal
Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15
Lamotrigine Compressed tablet 25mgDrug
Also called Lamictal
Single dose of lamotrigine compressed 25mg*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day15
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine (Lamictal) D/C 5mg*5, Crossover | Experimental | Single dose of lamotrigine dispersible/chewable (D/C)5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15 Receives: Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5; Drug: Lamotrigine Compressed tablet 25mg |
| Lamotrigine (Lamictal) Compressed 25mg, Crossover | Experimental | Single dose of lamotrigine compressed 25mg*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day15 Receives: Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5; Drug: Lamotrigine Compressed tablet 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to infinity [AUC(0-inf)], including bioequivalence evaluation
AUC(0-inf) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-inf) is defined as area under the concentration vs. time curve from zero to infinity.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Area under the concentration-time curve up to the last time point at which the concentration is above the lower limit of quantification [AUC(0-t)], including bioequivalence evaluation
AUC(0-t) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-t) is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
The observed maximum serum drug concentration (Cmax), including bioequivalence evaluation
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Secondary outcomes (3)
Time to reach Cmax (tmax)
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Elimination half-time (t½)
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Elimination rate constant, linear regression according to linear serum drug concentration-time curve
Measured: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study start28 Apr 2013
- Primary completion6 Jun 2013
- Study completion6 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01879423
- Sponsor's protocol ID
- 115207
- Status last verified
- May 2017
- First submitted
- 13 Jun 2013
- Last updated
- 1 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, Two-Period Crossover Study to Demonstrate the Bioequivalence of Lamotrigine Dispersible/Chewable Tablets (5mg×5) and Lamotrigine Compressed Tablet (25mg) in Healthy Chinese Male Subjects.
- ClinicalTrials.gov ID
- NCT01879423
- Acronym / sponsor ID
- 115207
- Conditions
- Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2013 (actual)
- Primary completion
- 6 Jun 2013 (actual)
- Study completion
- 6 Jun 2013 (actual)
- First posted
- 17 Jun 2013 (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 is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. The safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will also be assessed.
Detailed description
This is a single dose, open-label, randomized, two-period crossover study to demonstrate the bioequivalence of lamotrigine dispersible/chewable tablets (5mg×5) and lamotrigine compressed tablets (25mg) in healthy Chinese male subjects in fasting conditions. 24 healthy Chinese male subjects will be enrolled to provide data from at least 22 evaluable subjects . In Period 1, subjects will be randomized in equal numbers to be dosed with either lamotrigine dispersible/chewable 5mg×5 tablets or lamotrigine compressed tablet 25mg×1. Following a washout of at least 14 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.
Pharmacokinetic blood samples will be collected over 168 hours post dose. Venous blood (2 ml each) is taken immediately before dosing (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post dose to determine the lamotrigine concentration in serum. Drug concentration in serum at different time points will be determined for each subject with a validated bioanalytical method using LC/MS/MS method. The main pharmacokinetic parameters such as Cmax, tmax, AUC(0-inf), AUC(0-t), t1/2, λz, CL/F and Vd/F are calculated for subjects using non-compartment analysis method.
Physical examination, electrocardiogram and clinical laboratory tests are conducted at screening and 168 hours after administration of each dose; vital signs are measured at scheduled time; adverse events are recorded throughout the study. Clinically relevant safety measurement values are tabulated to evaluate the safety and tolerability of lamotrigine dispersible/chewable tablet. Safety evaluation lasts up to 168 hours after the second oral administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine (Lamictal) D/C 5mg*5, Crossover | Experimental | Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5, Drug: Lamotrigine Compressed tablet 25mgSingle dose of lamotrigine dispersible/chewable (D/C)5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15 |
| Lamotrigine (Lamictal) Compressed 25mg, Crossover | Experimental | Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5, Drug: Lamotrigine Compressed tablet 25mgSingle dose of lamotrigine compressed 25mg*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day15 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male non-smoker, based on medical history and physical examination.
- 18-40 years old, inclusive.
- Body weight >50 kg, and result of BMI is between 18.0 and 24.0 kg/m2, inclusive.
- Capable of returning to study site for follow-up according to the requirement of protocol and willing to comply with the policy, procedure and restriction of the study.
- Capable of reading and understanding the information listed in the consent form. Signing the informed consent prior to any study related procedure.
Key exclusion criteria (13 listed)
- Current or chronic history of cardiovascular, respiratory, gastrointestinal, endocrine, hepatic, hematological, psychical or nervous system diseases, use of drug that can change the absorption, metabolism or elimination of study drug, or result in danger or other drugs or diseases that interfere with the interpretation of study data.
- Personal or familial history of hypersensitivity to lamotrigine or drug with similar chemical composition.
- Participation in other clinical trial within 30 days prior to enrollment in the study.
- Use of prescription or non-prescription drugs, including monoamine oxidase inhibitor or herbal drug within 14 days prior to the screening; excluding use of lubricating oil or contraceptive barrier device containing spermicidal agents, and other contraception device.
- History of abnormality of liver function, abnormal hepatic or biliary system, or positive hepatitis B surface antigen (HBsAg), or positive hepatitis C surface antibody (HCAb) or ALT ≥ 2x upper limit of normal (ULN). Having Gilbert syndrome.
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 Dispersible/Chewable tablets 5mg*5Also: LamictalSingle dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15 | Drug | Lamotrigine (Lamictal) Compressed 25mg, Crossover, Lamotrigine (Lamictal) D/C 5mg*5, Crossover |
| Lamotrigine Compressed tablet 25mgAlso: LamictalSingle dose of lamotrigine compressed 25mg*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day15 | Drug | Lamotrigine (Lamictal) Compressed 25mg, Crossover, Lamotrigine (Lamictal) D/C 5mg*5, Crossover |
Primary outcome
Area under the concentration-time curve from time zero to infinity [AUC(0-inf)], including bioequivalence evaluation
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
AUC(0-inf) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-inf) is defined as area under the concentration vs. time curve from zero to infinity.
Area under the concentration-time curve up to the last time point at which the concentration is above the lower limit of quantification [AUC(0-t)], including bioequivalence evaluation
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
AUC(0-t) is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC(0-t) is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.
The observed maximum serum drug concentration (Cmax), including bioequivalence evaluation
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
3 secondary outcomes
Time to reach Cmax (tmax)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Elimination half-time (t½)
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Elimination rate constant, linear regression according to linear serum drug concentration-time curve
Time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
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 1 Jun 2017.
- 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 115207 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 Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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 Dispersible/Chewable tablets 5mg*5 and Lamotrigine Compressed tablet 25mg in people with Epilepsy, run by GlaxoSmithKline at 1 site in China.
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 11 inclusion and 13 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 1 Jun 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 China. 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?
Area under the concentration-time curve from time zero to infinity [AUC(0-inf)], including bioequivalence evaluation (time frame: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2017.