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About
The objective of this study was to compare the rate and extent of absorption of Purepac, a subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P., U.S.A. (Reminyl),galantamine, administered as a 1 x 4 mg tablet, under fed conditions.
Full description
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fed Conditions.
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Enrollment
Sex
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Volunteers
Inclusion criteria
Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, SFBC Anapharm Web site, SFBC Anapharm volunteers' database). Subjects must meet all of the following criteria in order to be included in the study:
Exclusion criteria
Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
Clinically significant surgery within 4 weeks prior to the administration of the study medication.
Use of prescription medication (including hormone therapy) within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption or hormonal contraceptive.
24 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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