Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
Summary
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fed conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Lamotrigine Tablets 25 mg, Lamictal® Tablets 25 mg
Location
Kendle International Inc.
Morgantown
West Virginia
United States
26505
Status
Completed
Source
Mylan Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00647751
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
Tablets
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Excipients
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
Clinical Trials
Fasting Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2...
Lamotrigine 25 mg Chewable Tablets, Non-Fasting
The objective of this study is to compare the rate and extent of absorption of lamotrigine 25 mg chewable dispersible tablets (test) versus Lamictal® (reference) administered as 2 x 25 mg...
- Objective: - To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tab...
- Objective: - A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Tor...
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of lamotrigine 200 mg tablets (test) versus Lamictal® (reference) administered as 1 x 200 mg tablet under fed c...
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