Overview

Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

Status:
Completed
Trial end date:
2000-04-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate, 100 mg.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Par Pharmaceutical, Inc.
Collaborator:
Anapharm
Treatments:
Doxycycline
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.