Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Collaborator:
Anapharm
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01380496
First received: April 1, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
To Determine Bioequivalence Under Fed Conditions.
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, 3-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 and Fed Conditions

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]
    Comparable food effect; The ratio of least-squares meansof the test to reference of AUCo-t, AUC -inf and Cmax should be within 80% to 125%.


Enrollment: 24
Study Start Date: November 1999
Study Completion Date: November 1999
Primary Completion Date: November 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B
Subjects received the Oclassen Pharmaceuticals Inc. formulated product.
Drug: doxycycline monohydrate
Capsule, 100 mg, single, oral dose
Other Name: Monodox (R)
Active Comparator: C
Subjects received the Oclassen Pharmaceuticals Inc. formulated product.
Drug: doxycycline monohydrate
Capsule, 100 mg, single, oral dose
Other Name: Monodox(R)
Experimental: A
Subjects received the Par formulated product
Drug: doxycycline monohydrate
tablet, 100 mg, single, oral dose
Other Name: Monodox(R)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380496

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada
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: NCT01380496     History of Changes
Other Study ID Numbers: 99118
Study First Received: April 1, 2008
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 14, 2014