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Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions

2014-08-27 03:20:02 | BioPortfolio

Summary

The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA), Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)

Status

Completed

Source

Sandoz Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:02-0400

Clinical Trials [1279 Associated Clinical Trials listed on BioPortfolio]

Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fed Conditions

The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fed conditions.

Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer

This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects with prostate cancer prior to it becoming commercially available. The patient will receive bic...

Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fed Conditions

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fed con...

Study of Bicalutamide 1 x 50 mg Tablet in Healthy Subjects Under Fasting Conditions

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablets (test) versus Casodex® (reference) administered as 1 x 50 mg tablet under fasting...

Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under fasting c...

PubMed Articles [3602 Associated PubMed Articles listed on BioPortfolio]

Enhanced Dissolution of Solid Dispersions Containing Bicalutamide Subjected to Mechanical Stress.

The anticancer drug bicalutamide was co-milled with either Macrogol6000 or Poloxamer407, and the physicochemical parameters that drive the phase transition of binary systems and influence the dissolut...

Tablets made from paper.

The possibility to compress ordinary paper into tablets was systematically investigated in this study. Results proved that tablets can be made from paper, independent of the type of paper used. The ta...

Comparison of the effect of the antiandrogen apalutamide (ARN-509) versus bicalutamide on the androgen receptor pathway in prostate cancer cell lines.

Apalutamide (ARN-509) is an antiandrogen that binds selectively to androgen receptors (AR) and does not show antagonist-to-agonist switch like bicalutamide. We compared the activity of ARN versus bica...

Androgen receptor signaling regulates T-type Ca channel expression and neuroendocrine differentiation in prostate cancer cells.

Therapies designed to reduce androgen production or receptor activation are effective in limiting prostate tumor growth. However, prolonged treatment with anti-androgen therapies results in the progre...

Effect of Crushing, Cutting into Half, or Grinding of Co-formulated Glecaprevir/Pibrentasvir Tablets on Pharmacokinetic Measurements in Healthy Subjects.

Glecaprevir (GLE) and pibrentasvir (PIB) are direct-acting antivirals coformulated as a combination tablet for once-daily treatment of chronic hepatitis C virus infection. The objective of this study ...

Medical and Biotech [MESH] Definitions

Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)

A film base coated with an emulsion designed for use with x-rays.

Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect. They include CAPSULES; LINIMENTS; OINTMENTS; PHARMACEUTICAL SOLUTIONS; POWDERS; TABLETS; etc.

Use of a device (film badge) for measuring exposure of individuals to radiation. It is usually made of metal, plastic, or paper and loaded with one or more pieces of x-ray film.

The measurement of radiation by photography, as in x-ray film and film badge, by Geiger-Mueller tube, and by SCINTILLATION COUNTING.

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