A Phase 1 interventional study of Lamotrigine Dispersible/Chewable tablets 5mg*5 and Lamotrigine Compressed tablet 25mg in Epilepsy, sponsored by GlaxoSmithKline. Completed at 1 site in China. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of lamotrigine dispersible/chewable (D/C)5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15
Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5 · Drug: Lamotrigine Compressed tablet 25mg
Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15
Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5 · Drug: Lamotrigine Compressed tablet 25mg
Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg\*1 tablet at Day15
Also known as: Lamictal
Single dose of lamotrigine compressed 25mg\*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg\*5 tablets at Day15
Also known as: Lamictal
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.
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
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.
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 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.
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
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
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline