Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions

NCT00652704 | Completed Phase 1

• 1 other identifier: 99062
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)

Conditions

To Determine Bioequivalence Under Fed Conditions

Keywords

Bioequivalence; Doxycycline Monohydrate; Fed

Outcome Measures

Primary Outcomes (1)

• Rate and extent of absorption

  72 hours

Study Arms (3)

A

EXPERIMENTAL

Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions

Drug: Doxycycline monohydrate

B

ACTIVE COMPARATOR

Subjects received the reference product, Monodox (Oclassen) under fed conditions

Drug: Monodox

C

EXPERIMENTAL

Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions

Drug: Doxycycline Monohydrate

Interventions

Doxycycline Monohydrate DRUG

Capsules, 100 mg, fed

Also known as: Monodox

A

Monodox DRUG

Capsules, 100 mg, fed

Also known as: Doxycycline Monohydrate

B

Eligibility Criteria

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

You may qualify if:

• Subjects will be males, non-smokers
• Between 18 and 55 years of age
• Subjects weight will be within 15% of their ideal body weight, based on 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 anormalities found during medical screening
• Any clinically significant history of ongoing problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs of drugs
• Clinically significant illnesses within 4 weeks of the administration of study medication
• Abnormal laboratory tests judged clinically significant
• ECG or vital sign abnormalities (clinically significant)
• History of allergic reactions to heparin
• Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study
• History of severe allergies or hay fever
• Active asthma or bronchospasm
• Positive urine drug screen at screening
• Positive testing for hepatitis B, hepatitis C or HIV at screening
• Use of 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) within 56 days prior to the 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
• Recent history of drug abuse or use of illegal drugs: soft drugs (marijuana, pot) use within 3 months of the screening visit and hard drugs (cocaine, PCP, crack) use within 1 year of the screening visit

Sponsors & Collaborators

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

Study Sites (1)

Anapharm, Inc.

Sainte-Foy, Quebec, G1V 2K8, 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: April 4, 2008
• Study Start: July 1, 1999
• Primary Completion: September 1, 1999
• Study Completion: September 1, 1999
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

CA (1)