Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions

To Determine Bioequivalence Under Fasting Conditions Clinical Trial

Official title:

Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of Par's and Oclassen's (Monodox) Doxycycline Monohydrate Capsules Administered as 1 x 100 mg Capsule in Healthy Adult Males Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653380
• Other study ID #: 99061
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: April 1, 2008
• Start date: September 1999
• Est. completion date: October 1999

Study information

• Verified date: April 2008
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).

Description:

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg of doxycycline by Par Pharmaceutical, Inc., USA (test) versus Monodox by Oclassen Pharmaceuticals, Inc., USA reference administered as a 1 x 100 mg capsule under fasting conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1999
• Est. primary completion date: October 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subjects will be males, non-smokers

• Between 18 and 55 years of age

• Subjects weight will be within 15% of their ideal body weight, based on 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 problems or problems known to interfere with the absorption, distribution, metabolism or excretion of drugs of drugs

• Clinically significant illnesses within 4 weeks of the administration of study medication

• Abnormal laboratory tests judged clinically significant

• ECG or vital sign abnormalities (clinically significant)

• History of allergic reactions to heparin

• Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical subinvestigator, contraindicates the subject's participation in the study

• History of severe allergies or hay fever

• Active asthma or bronchospasm

• Positive urine drug screen at screening

• Positive testing for hepatitis B, hepatitis C or HIV at screening

• Use of 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) within 56 days prior to the 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

• Recent history of drug abuse or use of illegal drugs: soft drugs (marijuana, pot) use within 3 months of the screening visit and hard drugs (cocaine, PCP, crack) use 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

• Subjects who have undergone clinically significant surgery within 4 weeks prior to the administration of the study medication

• Any reason which, in the opinion of the medical subinvestigator, 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
Capsules, 100 mg, single-dose
• Monodox
Capsules, 100 mg, single-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	Rate and extent of absorption		72 hours	No