Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition
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 fed condition in healthy adult human subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Lamotrigine Tablets 25 mg (2 × 25 mg Tablets) and 'LAMICTAL®' (Lamotrigine) Tablets 25 mg (2 × 25 mg Tablets) in Healthy Adult Human Subjects Under Fed Conditions.|
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 3 months ] [ Designated as safety issue: No ]Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.25, 02.50, 03.00, 03.25, 03.50, 04.00, 04.25, 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 10.00, 12.00, 14.00, 18.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.
|Study Start Date:||March 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: LAMICTAL®
Lamictal® (Lamotrigine) Tablets 25 mg of GlaxoSmithkline, USA
2 x 25 mg tablet once a day
Other Name: LAMICTAL®
Experimental: Lamotrigine Tablets 25 mg
Lamotrigine Tablets 25 mg of M/s Ipca Laboratories Limited, India
Drug: Lamotrigine Tablets 25 mg
2 x 25 mg tablet once a day
Other Name: Test Product
Objective of this pivotal study was to assess the bioequivalence between Test Product: Lamotrigine Tablets 25 mg (2 x 25 mg)of M/s Ipca Laboratories Limited, India and the corresponding Reference Product: LAMICTAL® (Lamotrigine) Tablets 25 mg (2 x 25 mg) of GlaxoSmithkline, USA, under fed condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 28 healthy adult subjects. In each study period, a single 2 X 25 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 26 days including washout period of at least 21 days between administrations of study drug in each study period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618825
|Cliantha Research Limited|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Manish Singhal, MBBS||Cliantha Research Limited|