Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

NCT01380483 | Completed Phase 1

• 1 other identifier: 99117
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

bioequivalence; doxycycline monohydrate; fasting

Outcome Measures

Primary Outcomes (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

Study Arms (2)

A

EXPERIMENTAL

Subjects received the Par formulated product

Drug: doxycycline monohydrate

B

ACTIVE COMPARATOR

Subjects received the Oclassen Pharmaceuticals formulated product.

Drug: doxycycline monohydrate

Interventions

doxycycline monohydrate DRUG

Tablets, 100 mg, single, oral dose

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Anapharm: collaborator

Study Sites (1)

Anapharm Inc.

Sainte-Foy, Quebec, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Eric Masson, Pharm.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: June 27, 2011
• Study Start: January 1, 2000
• Primary Completion: April 1, 2000
• Study Completion: April 1, 2000
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

CA (1)