Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions

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

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

Study Overview

• Status: Completed
• Conditions: To Determine Bioequivalence Under Fasting Conditions
• Intervention / Treatment: Drug: Doxycycline Monohydrate; Drug: Monodox

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions.	Drug: Doxycycline Monohydrate; Capsules, 100 mg, single-dose; Other Names: Monodox
Active Comparator: B; Subjects received Oclassen's product (Monodox) under fasting conditions.	Drug: Monodox; Capsules, 100 mg, single-dose; Other Names: Doxycycline Monohydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and extent of absorption	72 hours

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Anapharm
• Investigators: Principal Investigator: Eric Masson, Pharm.D., Anapharm

Study record dates

Study Major Dates

• Study Start: September 1, 1999
• Primary Completion (Actual): October 1, 1999
• Study Completion (Actual): October 1, 1999

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: April 1, 2008
• First Posted (Estimate): April 4, 2008

Study Record Updates

• Last Update Posted (Estimate): April 4, 2008
• Last Update Submitted That Met QC Criteria: April 1, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: bioequivalence; fasting; doxycycline monohydrate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 99061