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Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition

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ClinicalTrials.gov Identifier: NCT01888263
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lamotrigine Phase 1

Detailed Description:
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 200mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing Lamotrigine) Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC in healthy, adult, human subjects under fed conditions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine

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
Drug: Lamotrigine
Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other Name: LAMICTAL XR

Active Comparator: LAMICTAL XR
(containing Lamotrigine)Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC
Drug: Lamotrigine
Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other Name: LAMICTAL XR




Primary Outcome Measures :
  1. Area under curve(AUC) [ Time Frame: Blood samples were withdrawn at predose (0.00) and 1.00, 2.00, 3.00, 4.50, 6.00, 7.50, 9.00, 10.50, 12.00, 13.50, 15.00, 16.50, 18.00, 20.00, 22.00, 24.00, 26.00, 30.00, 36.00, 48.00,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 hours post-dose. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01888263


Locations
India
Bioserve Clinical Research Private Limited
Balanagar, Hyderabad, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Srinivas Yadav K, Dr. Bioserve Clinical Research Private Limited,

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01888263     History of Changes
Other Study ID Numbers: 672/09
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: September 2010

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Lamotrigine Extended Release
crossover

Additional relevant MeSH terms:
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers