Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fed Condition
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Lamotrigine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Ralph Scallion E.E, M.D., Principal Investigator, Affiliation: AAIPharma
Summary
The purpose of this study is to determine the pharmacokinetics and bioequivalence of
Lamotrigine formulations after administration of single doses to non-smoking, healthy males
and females under fed conditions
Clinical Details
Official title: Single Dose Two-Way Crossover, Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets With Lamictal 25 mg Chewable Tablets in Healthy Volunteers Under Fed Condition
Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence based on Cmax and AUC parameters
Detailed description:
A single-dose, two-way, bioequivalence study in up to 24 normal, non-smoking, healthy males
and females will be utilized to evaluate the pharmacokinetics and bioequivalence of
Lamotrigine chewable dispersible formulations under fed conditions.
Eligibility
Minimum age: 18 Years.
Maximum age: 41 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy males and females at least 18 years of age inclusive.
- Informed of the nature of the study and given written informed consent.
- 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. (Appendix I and
II).
Exclusion Criteria:
- Hypersensitivity to Lamotrigine' (Lamictal®), or similar compounds.
- Any history of a clinical condition which might affect drug absorption, metabolism
or excretion.
- Recent history (within 1 year) of mental illness, drug addiction, drug abuse or
alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or
difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- 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-therapeutic indications as judged by the attending
physician.
- Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
- If female, the subject is lactating or has a positive pregnancy test at screening and
prior to each of the two treatment periods. Females of child bearing potential must
use a medically acceptable method of contraception throughout the entire study period
and for one week after the study is completed. Medically acceptable methods of
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.
Locations and Contacts
AAI Clinic, Chapel Hill, North Carolina 27514, United States
Additional Information
Starting date: January 2003
Last updated: June 11, 2010
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