A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
Summary
The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.
Description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets in Healthy Adult Volunteers under Fed Conditions.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
VENLAFAXINE TABLETS 50 mg , single dose, Effexor® Tablets equivalent to 50 mg venlafaxine
Location
MDS Pharma Services
Saint-Laurent, Montreal
Quebec
Canada
H4R 2N6
Status
Completed
Source
Actavis Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00871364
- 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)
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