Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00939458
• Date of registration: 13/07/2009
• Prospective Registration: No
• Primary sponsor: Torrent Pharmaceuticals Limited
• Public title: Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions
• Scientific title: A Randomized, Open Label, Single Dose, Crossover, Bioequivalence Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects,Under Fed Conditions
• Date of first enrolment: April 1, 2008
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00939458
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

India

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult subjects of either sex between 18-55 years of age (inclusive), having a
body mass index (BMI) between 18 and 27 kg/m2

- Subjects who have no evidence of underlying disease during screening and whose
physical examination is performed within 21 days prior to commencement of the study.

- Subjects whose screening laboratory values are within normal limits or values outside
normal limits considered by the physician/Principal Investigator to be of no clinical
significance.

- Informed consent given in written form according to section 11.3 of the protocol.

- Female Subjects:

1. of child bearing potential practicing an acceptable method of birth control for
the duration of the study as judged by the investigator(s), such as condoms,
foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.

2. postmenopausal for at least 1 year.

3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or
hysterectomy has been performed on the subject)

Exclusion Criteria:

- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,
immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.

- Alcohol dependence, alcohol abuse or drug abuse within past one year.

- Moderate to heavy smoking (> 10 cigarettes/day) or consumption of tobacco products.

- History of difficulty in swallowing tablet.

- Clinically significant illness within 4 weeks before the start of the study

- Asthma, urticaria or other allergic type reactions after taking any medication.

- Positive urine drug screening, HIV, Hepatitis B & C tests.

- Any history of hypersensitivity to Lamotrigine.

- Existence of any surgical or medical condition, which, in the judgment of clinical
investigator might interfere with the pharmacokinetics of the drug or likely to
compromise the safety of the subject.

- Inability to communicate or co-operate with the investigator due to language problem,
attitude, poor mental development/impaired cerebral function.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Lamotrigine

Primary Outcome(s)

Bioequivalence

Secondary ID(s)

1087/06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors