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

• ClinicalTrials.gov Identifier: NCT00652704
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Last Update Posted: September 26, 2017
• Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Anapharm
• Information provided by: Par Pharmaceutical, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
To Determine Bioequivalence Under Fed Conditions	Drug: Doxycycline monohydrate; Drug: Monodox; Drug: Doxycycline Monohydrate	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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 Start Date: July 1999
• Actual Primary Completion Date: September 1999
• Actual Study Completion Date: September 1999

Arms and Interventions

Arm	Intervention/treatment
Experimental: A; Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions	Drug: Doxycycline monohydrate; Capsules, 100 mg, fed; Other Name: Monodox
Active Comparator: B; Subjects received the reference product, Monodox (Oclassen) under fed conditions	Drug: Monodox; Capsules, 100 mg, fed; Other Name: Doxycycline Monohydrate
Experimental: C; Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions	Drug: Doxycycline Monohydrate; Capsules, 100 mg, fasting; Other Name: Monodox

Outcome Measures

Primary Outcome Measures :

1. Rate and extent of absorption [ Time Frame: 72 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes 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 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

Contacts and Locations

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

• Responsible Party: Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
• ClinicalTrials.gov Identifier: NCT00652704
• Other Study ID Numbers: 99062
• First Posted: April 4, 2008
• Last Update Posted: September 26, 2017
• Last Verified: September 2017

Keywords provided by Par Pharmaceutical, Inc.:

Bioequivalence; Doxycycline Monohydrate; Fed

Additional relevant MeSH terms:

Disease; Pathologic Processes; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents