- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888757
Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition
June 26, 2013 updated by: Dr. Reddy's Laboratories Limited
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fed Conditions.
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
Study Overview
Detailed Description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 50 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing Lamotrigine) Extended Release tablets 50mg of GlaxoSmithKline Research Triangle Park, NC in healthy, adult, human subjects under fed conditions.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hyderabad
-
Balanagar, Hyderabad, India, 500 037
- Bioserve Clinical Research Private Limited
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Subjects were selected based on the following inclusion criteria:
- Provide written informed consent.
- Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
- Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m 2.
- Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
Female Subjects
- 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.
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Exclusion Criteria The subjects were excluded based on the following criteria during screening and during the study:
- Incapable of understanding the informed consent.
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
- Oral temperature is below 95.0°F or above 98.6°F.
- Pulse rate below 50/min or above 100/min.
- History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs or its ingredients.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Consumption of grapefruit for the past ten days prior to the check-in, in each period.
- Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
- Habit of tobacco chewing.
- Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
- Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
- Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
- Clinically significant abnormalities and / or with significant diseases.
- Confirmed positive in alcohol screening.
- Confirmed positive in urine cotinine test.
- Confirmed positive in selected drug of abuse.
- Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
- Confirmed positive in urine pregnancy test. xx. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lamotrigine Extended Release Tablets
Lamotrigine Extended Release Tablets, 25 mg, 50 mg, 100 mg, 200 mg and 300 mgof Dr. Reddy's Laboratories Limited
|
Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other Names:
|
Active Comparator: LAMICTAL XR
(containing Lamotrigine)Extended Release tablets 50 mg of GlaxoSmithKline Research Triangle Park, NC
|
Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under curve(AUC)
Time Frame: Predose (0.00) and 1.00, 2.00, 3.00, 4.50, 6.00, 7.50, 9.00, 10.50, 12.00, 13.50, 15.00, 16.50, 18.00, 20.00, 22.00, 24.00, 26.00, 30.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 post dose.
|
Predose (0.00) and 1.00, 2.00, 3.00, 4.50, 6.00, 7.50, 9.00, 10.50, 12.00, 13.50, 15.00, 16.50, 18.00, 20.00, 22.00, 24.00, 26.00, 30.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 post dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Estimate)
June 28, 2013
Last Update Submitted That Met QC Criteria
June 26, 2013
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Malnutrition
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anticonvulsants
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
Other Study ID Numbers
- 718/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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