Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions - Full Text View

Sponsor:	Par Pharmaceutical, Inc.
Collaborator:	Anapharm
Information provided by:	Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00653380

Purpose

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

Condition	Intervention	Phase
To Determine Bioequivalence Under Fasting Conditions	Drug: Doxycycline Monohydrate Drug: Monodox	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label
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

Resource links provided by NLM:

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:

Rate and extent of absorption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	September 1999
Study Completion Date:	October 1999
Primary Completion Date:	October 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions.	Drug: Doxycycline Monohydrate Capsules, 100 mg, single-dose Other Name: Monodox
Active Comparator: B Subjects received Oclassen's product (Monodox) under fasting conditions.	Drug: Monodox Capsules, 100 mg, single-dose Other Name: Doxycycline Monohydrate

Detailed Description:

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg of 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 conditions.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653380

Locations

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

Sponsors and Collaborators

Par Pharmaceutical, Inc.

Anapharm

Investigators

Principal Investigator:

Eric Masson, Pharm.D.

Anapharm

More Information

No publications provided

Responsible Party:	Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:	NCT00653380 History of Changes
Other Study ID Numbers:	99061
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:

bioequivalence
doxycycline monohydrate
fasting

Additional relevant MeSH terms:

Disease
Pathologic Processes
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012