Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions

Par Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

To Determine Bioequivalence Under Fasting Conditions

Treatments

Drug: Monodox

Drug: Doxycycline Monohydrate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00652795

40074

Details and patient eligibility

About

To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).

Full description

To compare the rate and extent of absorption of doxycycline 150 mg tablet (test) versus Monodox 50 mg capsule (reference) administered as 1 x 50 mg tablet or 3 x 50 mg capsules under fasting conditions.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or non-childbearing potential female, smoker or non-smokers
18 years of age and older
Non-childbearing potential female subjects is defined as post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration
Capable of consent

Exclusion criteria

Clinically significant illnesses within 4 weeks of the administration of study medication
Clinically significant surgery within 4 weeks prior to the administration of the study medication
Any clinically significant abnormality found during medical screening
Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
Abnormal laboratory tests judged clinically significant
Positive testing for hepatitis B, hepatitis C or HIV at screening
ECG abnormalities or vital sign abnormalities at screening
BMI greater than or equal to 30.0 kg/m2
History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week
History of drug abuse or use of illegal drugs: soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit or positive urine drug screen at screening
History of allergic reactions to heparin, doxycycline, or other related drugs
Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication
Use of an investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication.
Clinically significant history or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug
Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease
Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption
Difficulty to swallow study medication
Smoking more than 25 cigarettes per day Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in the study A depot injection or an implant of any drug within 3 months prior to administration of study medication
Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study)prior to the administration of the study medication (50 mL to 300 mL of whole blood within 30 days, 301 mL to 500 mL of whole blood within 45 days, or more than 500 mL of whole blood within 56 days prior to drug administration)
History or presence of clinically significant gastro-oesophageal reflux, stomach ulcers, or indigestions
History or presence of clinically significant severe renal or hepatic dysfunction
History or presence of clinically significant myasthenia gravis
Breast-feeding subject
Positive urine pregnancy screen