Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

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

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

Study Overview

• Status: Completed
• Conditions: To Determine Bioequivalence Under Fasting Conditions
• Intervention / Treatment: Drug: doxycycline monohydrate; Drug: doxycycline monohydrate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sainte-Foy, Quebec, Canada
      • Anapharm Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Subjects received the Par formulated product	Drug: doxycycline monohydrate; Capsule, 100 mg, single, oral dose; Other Names: Monodox(R); 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 Names: Monodox(R); Drug: doxycycline monohydrate; Tablets, 100 mg, single, oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Anapharm
• Investigators: Principal Investigator: Eric Masson, Pharm.D., Anapharm

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): April 1, 2000
• Study Completion (Actual): April 1, 2000

Study Registration Dates

• First Submitted: April 1, 2008
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: bioequivalence; fasting; doxycycline monohydrate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 99117