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

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

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 4, 2008
Last Update Posted Date September 26, 2017
Study Start Date  ICMJE July 1999
Actual Primary Completion Date September 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
Rate and extent of absorption [ Time Frame: 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
Official Title  ICMJE 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
Brief Summary To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE To Determine Bioequivalence Under Fed Conditions
Intervention  ICMJE
  • Drug: Doxycycline monohydrate
    Capsules, 100 mg, fed
    Other Name: Monodox
  • Drug: Monodox
    Capsules, 100 mg, fed
    Other Name: Doxycycline Monohydrate
  • Drug: Doxycycline Monohydrate
    Capsules, 100 mg, fasting
    Other Name: Monodox
Study Arms  ICMJE
  • Experimental: A
    Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions
    Intervention: Drug: Doxycycline monohydrate
  • Active Comparator: B
    Subjects received the reference product, Monodox (Oclassen) under fed conditions
    Intervention: Drug: Monodox
  • Experimental: C
    Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions
    Intervention: Drug: Doxycycline Monohydrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2008)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1999
Actual Primary Completion Date September 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652704
Other Study ID Numbers  ICMJE 99062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
Study Sponsor  ICMJE Par Pharmaceutical, Inc.
Collaborators  ICMJE Anapharm
Investigators  ICMJE
Principal Investigator: Eric Masson, Pharm.D. Anapharm
PRS Account Par Pharmaceutical, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP