NCT00774189 - Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions | Syfrah

Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

History of allergy to clarithromycin, erythromycin and related macrolides
Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
Female volunteers demonstrating a positive pregnancy screen.
Female volunteers who are currently breastfeeding.
Presence of values' which are clinically significantly different from normal reference ranges for haemoglobin, total white blood cells count, differential WBC count and platelet count
Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids
Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se- rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol
Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), epithelial cells (\>4/HPF), glucose, (positive) and protein (positive).
History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
History of any psychiatric illness. which may impair the ability to provide written informed consent.
Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 'unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
Use of any enzyme modifying drugs within 30 days prior to Day I of this study
Participation in any clinical trial within 12 weeks preceeding day 1 of study
+1 more criteria