NCT00871247 - A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions | Syfrah

Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

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.
Any clinically significant abnormality found during medical screening.
Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
Abnormal laboratory tests judged clinically significant.
Positive testing for hepatitis B, hepatitis C, or HN at screening.
EeG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[I Unit:= 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
History of allergic reactions to heparin, finasteride, or other related drugs.
Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication .
Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
+10 more criteria