Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition
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|ClinicalTrials.gov Identifier: NCT01618799|
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fasting State||Drug: Lamotrigine Tablets 25 mg Drug: Lamotrigine||Phase 1|
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 fasting 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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 Fasting Conditions.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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
- Bioequivalence is based on Cmax and AUC parameters. [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618799
|Cliantha Research Limited|
|Ahmedabad, Gujarat, India|
|Principal Investigator:||Dr. Manish Singhal, MBBS||Cliantha Research Limited|