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Trial record 16 of 215 for:    Lamotrigine

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

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ClinicalTrials.gov Identifier: NCT01879423
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Lamotrigine Dispersible/Chewable tablets 5mg*5 Drug: Lamotrigine Compressed tablet 25mg Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 28, 2013
Actual Primary Completion Date : June 6, 2013
Actual Study Completion Date : June 6, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

Arm Intervention/treatment
Experimental: Lamotrigine (Lamictal) D/C 5mg*5, Crossover
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
Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15
Other Name: Lamictal

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
Other Name: Lamictal

Experimental: Lamotrigine (Lamictal) Compressed 25mg, Crossover
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
Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15
Other Name: Lamictal

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
Other Name: Lamictal




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879423


Locations
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China
GSK Investigational Site
Shanghai, China, 200030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 115207
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01879423     History of Changes
Other Study ID Numbers: 115207
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Additional relevant MeSH terms:
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Lamotrigine
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers