Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Summary
The bioavailability of the oral disintegrating tablet formulations given without water will be similar to an equivalent dose of the standard oral tablet given with water.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Conditions
Healthy Volunteers
Intervention
Viagra 50 mg tablet, Formulation B ODT tablet 50 mg, Formulation C ODT tablet 50 mg, Formulation D ODT tablet 50 mg
Location
Pfizer Investigational Site
New Haven
Connecticut
United States
06511
Status
Completed
Source
Pfizer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00950404
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Dietary Supplements
Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)
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)
Polyethylene Glycols
Polymers of ETHYLENE OXIDE and water and their ethers. They vary in consistency from liquid to solid, depending on the molecular weight, indicated by a number following the name. They are used as SURFACTANTS, dispersing agents, solvents, ointment and suppository bases, vehicles, and tablet excipients. Some specific groups are lauromagrogols, nonoxynols, octoxynols and poloxamers.
Calcium Sulfate
A calcium salt that is used for a variety of purposes including: building materials, as a desiccant, in dentistry as an impression material, cast, or die, and in medicine for immobilizing casts and as a tablet excipient. It exists in various forms and states of hydration. Plaster of Paris is a mixture of powdered and heat-treated gypsum.
Poloxamer
A nonionic polyoxyethylene-polyoxypropylene block co-polymer with the general formula HO(C2H4O)a(-C3H6O)b(C2H4O)aH. It is available in different grades which vary from liquids to solids. It is used as an emulsifying agent, solubilizing agent, surfactant, and wetting agent for antibiotics. Poloxamer is also used in ointment and suppository bases and as a tablet binder or coater. (Martindale The Extra Pharmacopoeia, 31st ed)
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