Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380483
• Other study ID #: 99117
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: June 22, 2011
• Start date: January 2000
• Est. completion date: April 2000

Study information

• Verified date: June 2011
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

To compare the single-dose bioequivalence of Par and Oclassen (Monodox(R)), 100 mg doxycycline under fasting conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2000
• Est. primary completion date: April 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Disease
• To Determine Bioequivalence Under Fasting Conditions

Intervention

Drug:
• doxycycline monohydrate
Tablets, 100 mg, single, oral dose
• doxycycline monohydrate
Capsule, 100 mg, single, oral dose

Locations

Country	Name	City	State
Canada	Anapharm Inc.	Sainte-Foy	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	Anapharm

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No