To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions
Summary
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pain
Intervention
Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA), Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)
Status
Completed
Source
Sandoz Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00881231
- 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
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Fasted Bioavailability Study of Cilostazol Tablets, 50mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a...
Fasted Bioavailability Study of Cilostazol Tablets, 100 mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a...
Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions
The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a...
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available...
PubMed Articles
Pharmacokinetics and correlation analysis of cilostazol in healthy Korean subjects.
Background: Cilostazol is frequently used to treat and prevent thrombosis in Korean patients. Patients and methods: We performed the pharmacokinetic and correlation analysis of cilostazol in Korean he...
BACKGROUND: The antiplatelet drug cilostazol is efficacious for prevention of stroke recurrence compared with placebo. We designed the second Cilostazol Stroke Prevention Study (CSPS 2) to establish n...
Cilostazol is a selective inhibitor of type III phosphodiesterase that inhibits platelet aggregation. Cilostazol is a useful vasodilator, antithrombotic, and cardiotonic agent. Ultraviolet B (UVB) irr...
Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce restenosis after interventions in coronary or femoropopliteal arteries. We investigated whether periprocedural...
Aim: The abnormal proliferation of vascular smooth muscle cells (VSMCs) in arterial walls is an important pathogenic factor of vascular disorders such as atherosclerosis and restenosis after angioplas...
