Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions

• ClinicalTrials.gov Identifier: NCT00652704
• Recruitment Status: Completed
• First Posted: April 4, 2008
• Last Update Posted: September 26, 2017
• Sponsor: Par Pharmaceutical, Inc.
• Collaborator: Anapharm
• Information provided by: Par Pharmaceutical, Inc.

Tracking Information

• First Submitted Date: April 1, 2008
• First Posted Date: April 4, 2008
• Last Update Posted Date: September 26, 2017
• Study Start Date: July 1999
• Actual Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 1, 2008): Rate and extent of absorption [ Time Frame: 72 hours ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions
• Official Title: Randomized, Open-Label, 3-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 and Fed Conditions
• Brief Summary: To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
• Detailed Description: To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg 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 and fed conditions.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: To Determine Bioequivalence Under Fed Conditions

Intervention

• Drug: Doxycycline monohydrate
  Capsules, 100 mg, fed
  Other Name: Monodox
• Drug: Monodox
  Capsules, 100 mg, fed
  Other Name: Doxycycline Monohydrate
• Drug: Doxycycline Monohydrate
  Capsules, 100 mg, fasting
  Other Name: Monodox

Study Arms

• Experimental: A
  Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions
  Intervention: Drug: Doxycycline monohydrate
• Active Comparator: B
  Subjects received the reference product, Monodox (Oclassen) under fed conditions
  Intervention: Drug: Monodox
• Experimental: C
  Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions
  Intervention: Drug: Doxycycline Monohydrate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 1, 2008): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 1999
• Actual Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)

Eligibility Criteria

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 anormalities 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00652704
• Other Study ID Numbers: 99062
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
• Study Sponsor: Par Pharmaceutical, Inc.
• Collaborators: Anapharm

Investigators

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

• PRS Account: Par Pharmaceutical, Inc.
• Verification Date: September 2017