bioequivalence study of doxycycline monohydrate tablets under fasting conditions

Conditions: To Determine Bioequivalence Under Fasting Conditions

Summary: the purpose of this study is to compare the single-dose bioequivalence of par and oclassen doxycycline monohydrate, 100 mg.

to compare the single-dose bioequivalence of par and oclassen (monodox(r)), 100 mg doxycycline under fasting conditions.

Eligibility criteria:
inclusion criteria: * males, non-smokers, between 18-55 years of age * subjects' weight will be within 15% of their ideal weight based on the table of "desirable weight of adults", metropolitan life insurance company, 1983. * subjects should read, sign, and date an informed consent form prior to any study procedures * subjects must complete all screening procedures within 28 days prior to the administration of the study medication. exclusion criteria: * clinically significant abnormalities found during medical screening * any clinically significant history of ongoing gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases). * clinically significant illnesses within 4 weeks of the administration of study medication. * abnormal laboratory test judged clinically significant. * ecg or vital signs abnormalities (clinically significant). * history of allergic reactions to doxycycline or other related drugs (e.g., chlortetracycline, demeclocycline, minocycline and tetracycline). * history of allergic reactions to heparin. * any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study. * positive urine drug screen (see section viii) at screening * positive testing for hepatitis b, hepatitis c or hiv screening. * use of an investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication. * recent donation of plasma (500 ml) within 7 days or recent donation or significant loss of whole blood (450 ml) with 56 days prior to administration of the study medication. * history of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 unit = 150 ml of wine or 360 ml of beer or 45 ml of alcohol 40%) * recent history of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (pcp), crack) within 1 year of the screening visit. * subjects who have taken prescription medication 14 days preceding administration of study medication or over the counter products 7 days preceding administration of study medication, except for topical products without systemic absorption. * subjects who have taken any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, mao inhibitors, neuroleptics, verapamil, quinidine). * subjects who have undergone clinically significant surgery 4 weeks prior to the administration of the study medication. * any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.

Keywords: bioequivalence doxycycline monohydrate fasting