Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition

NCT01618799 | Completed Phase 1 DMC

• 1 other identifier: Ipca/BA/1264033
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.

Conditions

Fasting State

Outcome Measures

Primary Outcomes (1)

• Bioequivalence is based on Cmax and AUC parameters.

  Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 00.25, 00.5, 00.75, 01.00, 01.25, 01.50, 01.75, 02.00, 02.25, 02.50, 03.00, 03.25, 03.50, 04.00, 04.25, 05.00, 06.00, 08.00, 10.00, 12.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.

  3 months

Study Arms (2)

LAMICTAL®

ACTIVE COMPARATOR

Lamictal® (Lamotrigine) Tablets 25 mg of GlaxoSmithkline, USA

Drug: Lamotrigine

Lamotrigine Tablets 25 mg

EXPERIMENTAL

Lamotrigine Tablets 25 mg of M/s Ipca Laboratories Limited, India

Drug: Lamotrigine Tablets 25 mg

Interventions

Lamotrigine Tablets 25 mg DRUG

2 x 25 mg tablet once a day

Also known as: Test Product

Lamotrigine Tablets 25 mg

Lamotrigine DRUG

2 x 25 mg tablet once a day

Also known as: LAMICTAL®

LAMICTAL®

Eligibility Criteria

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

You may qualify if:

• Age: 18 to 45 years old, both inclusive.
• Sex: Males and/or non-pregnant, non-lactating females.
• A. Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to initiation of the study \& prior to check-in of each period. They must be using an acceptable form of contraception.
• B. Acceptable forms of contraception include the following:
• i. Intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
• ii. Barrier methods containing or used in conjunction with a spermicidal agent, or
• iii. Surgical sterilization or
• iv. Practicing sexual abstinence throughout the course of the study.
• C. Females will not be considered of childbearing potential if one one of the following is reported and documented on the medical history:
• i. Postmenopausal with spontaneous amenorrhea for at least one year, or
• ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• iii. Total hysterectomy and an absence of bleeding for at least 3 months.
• BMI: 18.5 to 24.9 weight in Kg / (height in meter)2 both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 24.94 rounds down to 24.9. while 18.45 rounds up to 18.5).
• Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
• Able to give written informed consent to participate in the study.

You may not qualify if:

• History of allergic responses to Lamotrigine or other related drugs, or any of its formulation ingredients.
• Have significant diseases or clinically significant abnormal findings during screening, \[medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) \& transvaginal ultrasonography (for female volunteers)\].
• Any disease or condition which might compromise the haemopoeitic gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
• History or presence of bronchial asthma.
• Use of any hormone replacement therapy within 3 months prior to study medication dosing.
• A depot injection or implant of any drug within 3 months prior to administration of study medication.
• Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
• History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• History of allergic response to heparin.
• A positive hepatitis screen (includes subtypes B \& C).
• A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
• Volunteers who have donated blood (1 unit or 450 ml) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study drug.
• History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, India

Location

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dr. Manish Singhal, MBBS

  Cliantha Research 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 11, 2012
• First Posted: June 13, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

IN (1)