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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888250
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

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
Area under curve(AUC) [ Time Frame: Blood samples were withdrawn at predose (0.00) and 2.00, 4.00, 6.00, 8.00, 9.00, 10.00, 12.00, 14.00, 15.50, 17.00, 18.50, 20.00, 21.50, 23.00, 24.50, 26.00, 27.50, 29.00, 36.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 hours post-dose. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition
Official Title  ICMJE An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions.
Brief Summary This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
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 fasting conditions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Lamotrigine
Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other Name: LAMICTAL XR
Study Arms  ICMJE
  • 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
    Intervention: Drug: Lamotrigine
  • Active Comparator: LAMICTAL XR
    (containing Lamotrigine)Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC
    Intervention: Drug: Lamotrigine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888250
Other Study ID Numbers  ICMJE 671/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Srinivas Yadav K, Dr. Bioserve Clinical Research Private Limited,
PRS Account Dr. Reddy's Laboratories Limited
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP