Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Anapharm
Information provided by:
Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier:
NCT00652795
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).


Condition Intervention Phase
To Determine Bioequivalence Under Fasting Conditions
Drug: Doxycycline Monohydrate
Drug: Monodox
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Doxycycline 150 mg Tablet and Monodox 50 mg Capsule Administered as 1 x 150 mg Tablet or 3 x 50 mg Capsules in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Rate and extent of absorption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions.
Drug: Doxycycline Monohydrate
Tablets, 150 mg, single-dose
Other Name: Monodox
Active Comparator: B
Subjects received the Oclassen's product (Monodox) Capsules under fasting conditions.
Drug: Monodox
Capsules 50 mg (3 x 50 mg dose), single-dose
Other Name: Doxycycline Monohydrate

Detailed Description:

To compare the rate and extent of absorption of doxycycline 150 mg tablet (test) versus Monodox 50 mg capsule (reference) administered as 1 x 50 mg tablet or 3 x 50 mg capsules under fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-childbearing potential female, smoker or non-smokers
  • 18 years of age and older
  • Non-childbearing potential female subjects is defined as post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration
  • Capable of consent

Exclusion Criteria:

  • Clinically significant illnesses within 4 weeks of the administration of study medication
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication
  • Any clinically significant abnormality found during medical screening
  • Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
  • Abnormal laboratory tests judged clinically significant
  • Positive testing for hepatitis B, hepatitis C or HIV at screening
  • ECG abnormalities or vital sign abnormalities at screening
  • BMI greater than or equal to 30.0 kg/m2
  • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week
  • History of drug abuse or use of illegal drugs: soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit or positive urine drug screen at screening
  • History of allergic reactions to heparin, doxycycline, or other related drugs
  • Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication
  • Use of an investigational drug or participation in an investigational study, within 30 days prior to administration of the study medication.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug
  • Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption
  • Difficulty to swallow study medication
  • Smoking more than 25 cigarettes per day Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in the study A depot injection or an implant of any drug within 3 months prior to administration of study medication
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study)prior to the administration of the study medication (50 mL to 300 mL of whole blood within 30 days, 301 mL to 500 mL of whole blood within 45 days, or more than 500 mL of whole blood within 56 days prior to drug administration)
  • History or presence of clinically significant gastro-oesophageal reflux, stomach ulcers, or indigestions
  • History or presence of clinically significant severe renal or hepatic dysfunction
  • History or presence of clinically significant myasthenia gravis
  • Breast-feeding subject
  • Positive urine pregnancy screen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652795

Locations
Canada, Quebec
Anapharm
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Anapharm
Investigators
Principal Investigator: Benoit Girard, M.D. Anapharm
  More Information

No publications provided

Responsible Party: Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc.
ClinicalTrials.gov Identifier: NCT00652795     History of Changes
Other Study ID Numbers: 40074
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Par Pharmaceutical, Inc.:
bioequivalence
doxycycline monohydrate
fasting

Additional relevant MeSH terms:
Disease
Pathologic Processes
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 29, 2014