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Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01380483
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
Anapharm
Information provided by:
Par Pharmaceutical, Inc.

Brief Summary:
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate, 100 mg.

Condition or disease Intervention/treatment Phase
To Determine Bioequivalence Under Fasting Conditions Drug: doxycycline monohydrate Phase 1

Detailed Description:
To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fasting conditions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Randomized, 2-way Crossover, Comparative Bioequivalence Study of Par Pharmaceutical Inc. (USA) and Oclassen Pharmaceuticals Inc. (USA) (Monodox(R)) Doxycycline Monohydrate Equivalent to 100 mg Doxycycline Administered as a Single Dose of 100 mg In Healthy Adult Males Under Fasting Conditions
Study Start Date : January 2000
Actual Primary Completion Date : April 2000
Actual Study Completion Date : April 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Subjects received the Par formulated product
Drug: doxycycline monohydrate
Tablets, 100 mg, single, oral dose
Active Comparator: B
Subjects received the Oclassen Pharmaceuticals formulated product.
Drug: doxycycline monohydrate
Capsule, 100 mg, single, oral dose
Other Name: Monodox(R)



Primary Outcome Measures :
  1. Bioequivalence
    To conclude bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males, non-smokers, between 18-55 years of age
  • Subjects' weight will be within 15% of their ideal weight based on the 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 gastrointestinal problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. chronic diarrhea, inflammatory bowel diseases).
  • Clinically significant illnesses within 4 weeks of the administration of study medication.
  • Abnormal laboratory test judged clinically significant.
  • ECG or vital signs abnormalities (clinically significant).
  • History of allergic reactions to doxycycline or other related drugs (e.g., chlortetracycline, demeclocycline, minocycline and tetracycline).
  • History of allergic reactions to heparin.
  • Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
  • Positive urine drug screen (see section VIII) at screening
  • Positive testing for hepatitis B, hepatitis C or HIV screening.
  • Use of an 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) with 56 days prior to 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 (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%)
  • Recent history of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack) 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 (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine).
  • Subjects who have undergone clinically significant surgery 4 weeks prior to the administration of the study medication.
  • Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380483


Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Anapharm
Investigators
Principal Investigator: Eric Masson, Pharm.D. Anapharm

Responsible Party: Alvin Elvin/Director of Biopharmaceutics, Par Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT01380483     History of Changes
Other Study ID Numbers: 99117
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
doxycycline monohydrate
fasting

Additional relevant MeSH terms:
Disease
Pathologic Processes
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents