The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 100mg Compared With Compressed Tablet 100 mg

NCT02064465 | Completed Phase 1

• 1 other identifier: 200697
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomised, parallel-group study to demonstrate the bioequivalence of lamotrigine 100mg in two different formulations, dispersible/chewable tablet and compressed tablet, in healthy subjects under fasting conditions. Subjects will be randomized in equal numbers to be dosed with either lamotrigine dispersible/chewable (Test) 100mg tablet or lamotrigine compressed (Reference) 100mg tablet. Pharmacokinetic blood sampling will be collected over 216 hours post dose. Safety (tolerability) will be observed up to 216 hours post dose. Safety assessments will include regular monitoring of vital signs, ECG's, adverse events (AEs) and safety laboratory tests. A follow-up visit is scheduled within 10-17 days post-dose.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve [AUC(0-inf)] of lamotrigine if coefficients of variation (CV)% of λz<=30%, or AUC(0-inf)• λz if CV% of λz >30%, or AUC(0-t) if AUC(0-inf) cannot be accurately determined, including bioequivalence evaluation

  pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216 hours post-dose

• The observed maximum serum drug concentration (Cmax), including bioequivalence evaluation

  pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216 hours post-dose

Secondary Outcomes (4)

• Time to reach Cmax (Tmax) as data permit.

  pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216 hours post-dose

• Elimination half-time (t1/2) as data permit

  pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216 hours post-dose

• Elimination rate constant, linear regression according to linear serum drug concentration-time curve (λz) as data permit.

  pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216 hours post-dose

• Safety and tolerability as measured by adverse events, vital sign, ECG and clinical laboratory measurements.

  at screeing, Day0-10, follow-up visit

Study Arms (2)

Lamotrigine Dispersable/Chewable

EXPERIMENTAL

lamotrigine dispersible/chewable tablet 100mg

Drug: Lamotrigine Dispersible/Chewable tablet

Lamotrigine Compressed

EXPERIMENTAL

lamotrigine compressed tablet 100mg

Drug: Lamotrigine Compressed tablet

Interventions

Lamotrigine Dispersible/Chewable tablet DRUG

Single dose of lamotrigine dispersible/chewable 100mg tablet at Day1

Also known as: Lamictal

Lamotrigine Dispersable/Chewable

Lamotrigine Compressed tablet DRUG

Single dose of lamotrigine compressed 100mg tablet at Day1

Also known as: Lamictal

Lamotrigine Compressed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese male non-smoker, based on medical history and physical examination, aged between 18 and 45 years of age inclusive, at the time of signing the informed consent.

You may not qualify if:

• Body weight \>= 50 kg and BMI within the range 19 - 24 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.
• Aspartate transaminase (AST), Alanine transaminase (ALT), alkaline phosphatase (ALP) and total bilirubin \<= 1.5✕Upper limit of normal (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, inclusive, diastolic blood pressure \< 90mmHg) and pulse rate (60-100, inclusive).
• No clinically significant abnormality on 12-lead ECG.
• Corrected QT interval (QTc) \< 450 ms; or corrected QT interval \< 480 ms for subjects with bundle-branch block, based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period.
• Male subjects with female partners of child-bearing potential must use one of the contraceptive methods after the first dose of study treatment and until the follow-up visit.
• Current or chronic history of cardiovascular, respiratory, gastrointestinal, endocrine, 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.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities or Gilbert's syndrome (with the exception of asymptomatic gallstones).
• 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.
• History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>14 drinks. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
• Consumption of grapefruit or grapefruit juice within 7 days prior to first dose of study medication.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• History of asthma, anaphylaxis or anaphylactic reactions, severe allergic responses.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Shanghai, 200030, China

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 200697 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: March 15, 2014
• Primary Completion: July 8, 2014
• Study Completion: July 8, 2014
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)