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

Information source: Par Pharmaceutical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: To Determine Bioequivalence Under Fed Conditions.

Intervention: Doxycycline monohydrate (Drug); Monodox (Drug); Doxycycline Monohydrate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Par Pharmaceutical, Inc.

Official(s) and/or principal investigator(s):
Eric Masson, Pharm.D., Principal Investigator, Affiliation: Anapharm

Summary

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

Clinical Details

Official title: Randomized, Open-Label, 3-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 and Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Rate and extent of absorption

Detailed description: To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline by Par Pharmaceutical Inc., USA (test) versus Monodox by Oclassen Pharmaceuticals, Inc., USA (reference) administered as a 1 x 100 mg capsule under fasting and fed conditions.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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 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

Locations and Contacts

Anapharm, Inc., Sainte-Foy, Quebec G1V 2K8, Canada
Additional Information

Starting date: July 1999
Last updated: April 1, 2008

Page last updated: August 23, 2015

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