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CompletedNCT01513720Updated Jan 20, 2012

Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition

A Phase 1 interventional study of Lamotrigine and Lamictal® in Healthy, sponsored by Dr. Reddy's Laboratories Limited. Completed at 1 site in United States. Open to participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-20.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
All
01

Study summary

This is an single dose,two-way, crossover, oral bioequivalence study.

Read the detailed description

The study was an single dose, two-way crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fasting condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Lamotrigine
  • crossover
03

In context

Lead sponsor

Dr. Reddy's Laboratories Limited is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males and females at least 18 years of age inclusive
  2. Informed of the nature of the study and given written informed consent
  3. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion criteria

Exclusion Criteria:

  1. Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds
  2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion
  3. Recent history of mental illness, drug addition,drug abuse or alcoholism
  4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
  5. Received an investigational drug within the 4 weeks prior to study dosing.
  6. Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.
  7. Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
  8. If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Lamotrigine Tablets 200 mg

    Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited

    Drug: Lamotrigine · Drug: Lamictal®

  • Active comparator
    Lamictal® 200 mg Tablets

    Lamictal® 200 mg Tablets of GlaxoSmithKline Inc

    Drug: Lamotrigine · Drug: Lamictal®

Interventions

  • DrugLamotrigine

    Lamotrigine Tablets 200 mg

    Also known as: Lamictal® 200 mg

  • DrugLamictal®

    Lamictal® 200 mg Tablets

06

What researchers measure

Primary outcomes

  1. Area under curve (AUC)

    Time frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours

07

Study locations

1 site
  • AAI Clinic
    Quadrangle drive, North Carolina 27514, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01513720
Lead sponsor
Dr. Reddy's Laboratories Limited
Responsible party
Sponsor
First posted
Jan 20, 2012
Start date
Dec 2002
Primary completion
Dec 2002
Completion
Dec 2002
Last update
Jan 20, 2012

Study contacts

Dr. Ralph Scallion, MD
principal investigator · AAI Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2002. You cannot join it, but the record below documents what was studied.

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