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

• Status: Completed
• Trial end date: 2013-06-06
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

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.