A Phase 1 interventional study of Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA) and Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA) in Prostate Cancer and Hirsutism, sponsored by Sandoz. Completed. Open to male participants aged 19 Years to 63 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-28.
Sponsored by Sandoz (formerly part of Novartis) · Phase 1, Interventional, and Treatment
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sandoz is the lead sponsor of 139 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
First submitted before Sandoz left Novartis.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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The human immunodeficiency virus, which weakens the immune system.
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Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Drug: Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA)
Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Drug: Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
Bioequivalence based on AUC and Cmax
Time frame: 11 days
No study locations are listed for this record.
The record gives a start of Aug 2006, a primary completion of Aug 2006 and a completion of Aug 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bicalutamide