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1 Trial |
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1 Trial |  |
19 News |  |
- | lamotrigine extended release / Generic mfg.
Journal: Quantitative determination of related substances for Lamotrigine extended release tablet by RP-HPLC. (Pubmed Central) - May 22, 2023
Lamotrigine extended release tablet dosage form LAMICTAL XR used as an anticonvulsant in the treatment of generalized tonic clonic, absence seizures and partial seizures...Accuracy performed at LOQ to 250% level and recovery was found to be in the range of 95% to 105%. Therefore the developed related substances method provides a safe, easy and reproducible for the stability studies and QC release testing for the estimation of related substances.
- | lamotrigine extended release / Generic mfg.
Journal: Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study. (Pubmed Central) - Oct 20, 2022
Therefore the developed related substances method provides a safe, easy and reproducible for the stability studies and QC release testing for the estimation of related substances. The generic lamotrigine ER tablet product demonstrates BE to the brand product in fully replicated BE study design with healthy subjects, supporting the adequacy of two-way crossover study design to demonstrate BE and generic-brand substitution of lamotrigine ER products.
- | lamotrigine extended release / Generic mfg., bupropion ER / Generic mfg.
New P2 trial: Lamotrigine and Bupropion for Meniere's Disease (clinicaltrials.gov) - Jun 15, 2022
P2, N=34, Recruiting, Sponsor: Dent Neuroscience Research Center
- lamotrigine extended release / Generic mfg.
Phase classification, Trial completion date: A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects (clinicaltrials.gov) - Mar 16, 2018
P1, N=30, Completed, Sponsor: Food and Drug Administration (FDA)
The generic lamotrigine ER tablet product demonstrates BE to the brand product in fully replicated BE study design with healthy subjects, supporting the adequacy of two-way crossover study design to demonstrate BE and generic-brand substitution of lamotrigine ER products. Phase classification: P4 --> P1 | Trial completion date: Jan 2017 --> Apr 2017
- ||| lamotrigine extended release / Generic mfg.
New P3 trial, Monotherapy: A study of lamotrigine used alone in children with typical absence seizures. (EUDRACT) - Aug 31, 2017
P3, N=20, , Sponsor: GlaxoSmithKline KK
- | lamotrigine extended release / Generic mfg.
Trial completion: A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects (clinicaltrials.gov) - Feb 28, 2017
P4, N=30, Completed, Sponsor: Food and Drug Administration (FDA)
Phase classification: P4 --> P1 | Trial completion date: Jan 2017 --> Apr 2017 Recruiting --> Completed
- | lamotrigine extended release / Generic mfg.
New P4 trial: A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects (clinicaltrials.gov) - Jul 1, 2016
P4, N=30, Recruiting, Sponsor: Food and Drug Administration (FDA)
- ||| lamotrigine extended release / Generic mfg.
New P1 trial: Lamotrigine Extended-Release Tablets 50 mg Under Fed Condition (clinicaltrials.gov) - Jun 26, 2013
P1, N=62, Completed, Sponsor: Dr. Reddy's Laboratories Limited
- ||| lamotrigine extended release / Generic mfg.
New P1 trial: Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition (clinicaltrials.gov) - Jun 26, 2013
P1, N=62, Completed, Sponsor: Dr. Reddy's Laboratories Limited
- | lamotrigine extended release / Generic mfg.
New P1 trial: Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition (clinicaltrials.gov) - Jun 25, 2013
P1, N=32, Completed, Sponsor: Dr. Reddy's Laboratories Limited
- | lamotrigine extended release / Generic mfg.
New P1 trial: Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition (clinicaltrials.gov) - Jun 25, 2013
P1, N=36, Completed, Sponsor: Dr. Reddy's Laboratories Limited
- | lamotrigine extended release / Generic mfg.
Trial completion: Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fed Condition (clinicaltrials.gov) - Jun 24, 2013
P1, N=32, Completed, Sponsor: Dr. Reddy's Laboratories Limited
Recruiting --> Completed Not yet recruiting --> Completed
- | lamotrigine extended release / Generic mfg.
Trial completion: Bioequivalence Study of Lamotrigine Extended-Release Tablets 200mg Under Fasting Condition (clinicaltrials.gov) - Jun 24, 2013
P1, N=36, Completed, Sponsor: Dr. Reddy's Laboratories Limited
Not yet recruiting --> Completed Not yet recruiting --> Completed