NCT01380483CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Par Pharmaceutical, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Bioequivalence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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,
- •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.
Arms & Interventions
A
Experimental
Subjects received the Par formulated product
Intervention: doxycycline monohydrate (Drug)
B
Active Comparator
Subjects received the Oclassen Pharmaceuticals formulated product.
Intervention: doxycycline monohydrate (Drug)
Outcomes
Primary Outcomes
Bioequivalence
To conclude bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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