Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions

Inclusion Criteria:

• Subjects will be males, non-smokers
• Between 18 and 55 years of age
• Subjects weight will be within 15% of their ideal body weight, based on 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 anormalities found during medical screening
• Any clinically significant history of ongoing problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs of drugs
• Clinically significant illnesses within 4 weeks of the administration of study medication
• Abnormal laboratory tests judged clinically significant
• ECG or vital sign abnormalities (clinically significant)
• History of allergic reactions to heparin
• Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
• History of severe allergies or hay fever
• Active asthma or bronchospasm
• Positive urine drug screen at screening
• Positive testing for hepatitis B, hepatitis C or HIV at screening
• Use of 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) within 56 days prior to the 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
• Recent history of drug abuse or use of illegal drugs: soft drugs (marijuana, pot) use within 3 months of the screening visit and hard drugs (cocaine, PCP, crack) use 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
• Subjects who have undergone clinically significant surgery within 4 weeks prior to the administration of the study medication
• Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study