The Bioequivalence Study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared With Lamotrigine Compressed Tablet 25mg in Chinese Healthy Male Subjects

NCT01879423 | Completed Phase 1

• 1 other identifier: 115207
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. The safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will also be assessed.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  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)

  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

  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

Study Arms (2)

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

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

Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5; Drug: Lamotrigine Compressed tablet 25mg

Interventions

Lamotrigine Dispersible/Chewable tablets 5mg*5 DRUG

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

Lamotrigine (Lamictal) Compressed 25mg, Crossover; Lamotrigine (Lamictal) D/C 5mg*5, Crossover

Lamotrigine Compressed tablet 25mg DRUG

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

Lamotrigine (Lamictal) Compressed 25mg, Crossover; Lamotrigine (Lamictal) D/C 5mg*5, Crossover

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male non-smoker, based on medical history and physical examination.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

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 115207 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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 17, 2013
• Study Start: April 28, 2013
• Primary Completion: June 6, 2013
• Study Completion: June 6, 2013
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)