Clinical trial NCT01380483: Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: To Determine Bioequivalence Under Fasting Conditions
Keywords: bioequivalence
doxycycline monohydrate
fasting
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Anapharm
First posted: 2011-06-27
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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 fasting conditions.

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.

Primary outcomes:
measure: Bioequivalence
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte-Foy
country: Canada
facility: Anapharm Inc.
state: Quebec
Study officials:
affiliation: Anapharm
name: Eric Masson, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: