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

This study has been completed.
Sponsor:
Collaborator:
Anapharm
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00652704
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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 Fed Conditions.
Drug: Doxycycline monohydrate
Drug: Monodox
Drug: Doxycycline Monohydrate
Phase 1

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

Resource links provided by NLM:


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: July 1999
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652704

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: NCT00652704     History of Changes
Other Study ID Numbers: 99062
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
Fed

Additional relevant MeSH terms:
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 20, 2014