Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

• Sponsor: Par Pharmaceutical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01380483
• Collaborator: Anapharm (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate, 100 mg.

Condition or Disease	Intervention/Treatment	Phase
To Determine Bioequivalence Under Fasting Conditions	Drug: doxycycline monohydrate; Drug: doxycycline monohydrate	Phase 1

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
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• 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 Start Date: Jan 1, 2000
• Actual Primary Completion Date: Apr 1, 2000
• Actual Study Completion Date: Apr 1, 2000

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Subjects received the Par formulated product	Drug: doxycycline monohydrate; Tablets, 100 mg, single, oral dose
Active Comparator: B Subjects received the Oclassen Pharmaceuticals formulated product.	Drug: doxycycline monohydrate; Capsule, 100 mg, single, oral dose; Other Names: Monodox(R)

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: 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, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anapharm Inc.	Sainte-Foy	Quebec	Canada

Sponsors and Collaborators

• Par Pharmaceutical, Inc.
• Anapharm

Investigators

• Principal Investigator: Eric Masson, Pharm.D., Anapharm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01380483
• Other Study ID Numbers: 99117
• First Posted: Jun 27, 2011
• Last Update Posted: Jun 27, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: bioequivalence; doxycycline monohydrate; fasting
• Additional relevant MeSH terms: Disease; Doxycycline

Study Results

No Results Posted as of Jun 27, 2011