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CompletedNCT00652704Updated Sep 26, 2017

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

A Phase 1 interventional study of Doxycycline monohydrate and Monodox in To Determine Bioequivalence Under Fed Conditions, sponsored by Par Pharmaceutical, Inc.. Completed at 1 site in Canada. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-26.

Sponsored by Par Pharmaceutical, Inc. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • To Determine Bioequivalence Under Fed Conditions

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Keywords

  • Bioequivalence
  • Doxycycline Monohydrate
  • Fed
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    A

    Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions

    Drug: Doxycycline monohydrate

  • Active comparator
    B

    Subjects received the reference product, Monodox (Oclassen) under fed conditions

    Drug: Monodox

  • Experimental
    C

    Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions

    Drug: Doxycycline Monohydrate

Interventions

  • DrugDoxycycline monohydrate

    Capsules, 100 mg, fed

    Also known as: Monodox

  • DrugMonodox

    Capsules, 100 mg, fed

    Also known as: Doxycycline Monohydrate

  • DrugDoxycycline Monohydrate

    Capsules, 100 mg, fasting

    Also known as: Monodox

05

What researchers measure

Primary outcomes

  1. Rate and extent of absorption

    Time frame: 72 hours

06

Study locations

1 site
  • Anapharm, Inc.
    Sainte-Foy, Quebec G1V 2K8, Canada
07

Registry details

Key details

Study ID
NCT00652704
Lead sponsor
Par Pharmaceutical, Inc.
Collaborators
Anapharm
First posted
Apr 4, 2008
Start date
Jul 1999
Primary completion
Sep 1999
Completion
Sep 1999
Last update
Sep 26, 2017

Study contacts

Eric Masson, Pharm.D.
principal investigator · Anapharm

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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