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

NCT01888250 | Completed Phase 1

• 1 other identifier: 671/09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioequivalence; Lamotrigine Extended Release; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve(AUC)

  Blood samples were withdrawn at predose (0.00) and 2.00, 4.00, 6.00, 8.00, 9.00, 10.00, 12.00, 14.00, 15.50, 17.00, 18.50, 20.00, 21.50, 23.00, 24.50, 26.00, 27.50, 29.00, 36.00, 48.00,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.

Study Arms (2)

Lamotrigine Extended Release Tablets

EXPERIMENTAL

Lamotrigine Extended Release Tablets, 25 mg, 50 mg, 100 mg, 200 mg and 300 mgof Dr. Reddy's Laboratories Limited

Drug: Lamotrigine

LAMICTAL XR

ACTIVE COMPARATOR

(containing Lamotrigine)Extended Release tablets 200mg of GlaxoSmithKline Research Triangle Park, NC

Drug: Lamotrigine

Interventions

Lamotrigine DRUG

Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg

Also known as: LAMICTAL XR

LAMICTAL XR; Lamotrigine Extended Release Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Private Limited

Bālānagar, Hyderabad, 500 037, India

Location

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Srinivas Yadav K, Dr.

  Bioserve Clinical Research Private Limited,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: August 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 27, 2013

Record last verified: 2010-09

Locations

IN (1)