Last updated: 11/07/2018 08:56:55
The Bioequivalence study of Lamotrigine Dispersible/Chewable Tablets 5mg×5 Compared with Lamotrigine Compressed Tablet 25mg in Chinese healthy male subjectsN/A
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial 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. The safety, tolerability and pharmacokinetic profile of lamotrigine dispersible/chewable tablets will also be assessed.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Area under the concentration-time curve from time zero to infinity [AUC(0-inf)], including bioequivalence evaluation
Timeframe: 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
Timeframe: 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
Timeframe: 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:
Time to reach Cmax (tmax)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Interventions:
Enrollment:
24
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Yan Li, Dongjun Su, Rongxuan Zhu, Jiansong Yang, Huafang Li. Bioequivalence studies of lamotrigine dispersible/chewable tablets compared to lamotrigine compressed tablets in Chinese healthy male subjects. The 5th International Symposium of Quantitative Pharmacology In Drug Development and Regulation. 2015;Sept
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
April 2013 to June 2013
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- Healthy male non-smoker, based on medical history and physical examination.
- 18-40 years old, inclusive.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2013-06-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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