Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Anapharm
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT01380483
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 Fasting 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, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]
    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


Enrollment: 40
Study Start Date: January 2000
Study Completion Date: April 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alvin Elvin/Director of Biopharmaceutics, Par Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT01380483     History of Changes
Other Study ID Numbers: 99117
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
fasting

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

ClinicalTrials.gov processed this record on August 28, 2014