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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. (part of Par Health) · 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

Keywords

  • Bioequivalence
  • Doxycycline Monohydrate
  • Fed
03

In context

Lead sponsor

Par Pharmaceutical, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

First submitted before Par Pharmaceutical, Inc. became part of Par Health.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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:

  • 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
  • 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 , or at screening
  • Use of 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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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

06

What researchers measure

Primary outcomes

  1. Rate and extent of absorption

    Time frame: 72 hours

07

Study locations

1 site
  • Anapharm, Inc.
    Sainte-Foy, Quebec G1V 2K8, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 1999, a primary completion of Sep 1999 and a completion of Sep 1999. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2008
First posted
Apr 4, 2008
Start
Jul 1999
Primary completionActual
Sep 1999
CompletionActual
Sep 1999
Last update
Sep 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00652704
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 ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Doxycycline

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