Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions

NCT ID: NCT01380496

Last Updated: 2017-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30
• Study Completion Date: 1999-11-30

Brief Summary

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

Detailed Description

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

Conditions

To Determine Bioequivalence Under Fed Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

B

Subjects received the Oclassen Pharmaceuticals Inc. formulated product.

Group Type: ACTIVE_COMPARATOR

doxycycline monohydrate

Intervention Type: DRUG

Capsule, 100 mg, single, oral dose

C

Subjects received the Oclassen Pharmaceuticals Inc. formulated product.

Group Type: ACTIVE_COMPARATOR

doxycycline monohydrate

Intervention Type: DRUG

Capsule, 100 mg, single, oral dose

A

Subjects received the Par formulated product

Group Type: EXPERIMENTAL

doxycycline monohydrate

Intervention Type: DRUG

tablet, 100 mg, single, oral dose

Interventions

doxycycline monohydrate

tablet, 100 mg, single, oral dose

Intervention Type: DRUG

doxycycline monohydrate

Capsule, 100 mg, single, oral dose

Intervention Type: DRUG

doxycycline monohydrate

Capsule, 100 mg, single, oral dose

Intervention Type: DRUG

Other Intervention Names

Monodox(R); Monodox (R); Monodox(R)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anapharm

INDUSTRY

Sponsor Role: collaborator

Par Pharmaceutical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Par Pharmaceutical Inc.

Principal Investigators

Eric Masson, Pharm D.

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

Anapharm Inc.

Sainte-Foy, Quebec, Canada

Countries

Canada

Other Identifiers

99118

Identifier Type: -

Identifier Source: org_study_id