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Lamotrigine Extended-Release Tablets 50 mg 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):
Vimal Teja P, Dr., Principal Investigator, Affiliation: Bioserve Clinical Research Private Limited,

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under curve(AUC)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

Locations and Contacts

Bioserve Clinical Research Private Limited, Balanagar, Hyderabad 500 037, India
Additional Information

Starting date: September 2010
Last updated: June 26, 2013

Page last updated: August 23, 2015

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