Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions

• Status: Completed
• Trial end date: 1999-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Anapharm
• Treatments: Doxycycline

Criteria

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 abnormalities 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