Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions

NCT01380496 | Completed Phase 1

• 1 other identifier: 99118
• Study Type: interventional
• Target: 24
• 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 Fed Conditions

Keywords

bioequivalence; doxycycline monohydrate; fed

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  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%.

Study Arms (3)

B

ACTIVE COMPARATOR

Subjects received the Oclassen Pharmaceuticals Inc. formulated product.

Drug: doxycycline monohydrate

C

ACTIVE COMPARATOR

Subjects received the Oclassen Pharmaceuticals Inc. formulated product.

Drug: doxycycline monohydrate

A

EXPERIMENTAL

Subjects received the Par formulated product

Drug: doxycycline monohydrate

Interventions

doxycycline monohydrate DRUG

tablet, 100 mg, single, oral dose

Also known as: Monodox(R)

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

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: June 27, 2011
• Study Start: November 1, 1999
• Primary Completion: November 1, 1999
• Study Completion: November 1, 1999
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

CA (1)