To Determine Bioequivalence Under Fasting Conditions Clinical Trial
Official title:
Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of Par's and Oclassen's (Monodox) Doxycycline Monohydrate Capsules Administered as 1 x 100 mg Capsule in Healthy Adult Males Under Fasting Conditions
Verified date | April 2008 |
Source | Par Pharmaceutical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).
Status | Completed |
Enrollment | 24 |
Est. completion date | October 1999 |
Est. primary completion date | October 1999 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Anapharm, Inc. | Sainte-Foy | Quebec |
Lead Sponsor | Collaborator |
---|---|
Par Pharmaceutical, Inc. | Anapharm |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate and extent of absorption | 72 hours | No |
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