Fed Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01721187 -
Satiety Effects on the Neural Valuation of Food
|
N/A | |
| Completed |
NCT01827878 -
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fed Conditions
|
Phase 1 | |
| Completed |
NCT01372306 -
Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01283932 -
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
|
Phase 1 | |
| Completed |
NCT03390881 -
Use of Breath Acetone aa a Marker of Energy Balance
|
N/A | |
| Completed |
NCT01283867 -
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Non-Fasting Conditions
|
Phase 1 | |
| Completed |
NCT01503450 -
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01618760 -
Bioequivalence Study of Risperidone Tablet 1 mg Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01735383 -
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01578265 -
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
|
Phase 1 | |
| Recruiting |
NCT05837572 -
Development of the Leeds Food Preference Questionnaire in Spanish
|
N/A | |
| Completed |
NCT01505998 -
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
|
Phase 1 | |
| Completed |
NCT01735344 -
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01372358 -
Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Non-Fasting Conditions
|
Phase 1 | |
| Completed |
NCT01567501 -
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition
|
Phase 1 | |
| Completed |
NCT05995119 -
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers
|
Early Phase 1 | |
| Completed |
NCT01314352 -
Bioavailability Study of Desloratadine 5 mg Tablet of Dr. Reddy's Under Fed Conditions
|
Phase 1 | |
| Completed |
NCT01744873 -
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
|
Phase 1 | |
| Completed |
NCT01503424 -
Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study
|
Phase 1 | |
| Completed |
NCT01884909 -
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fed Conditions
|
Phase 1 |