Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Meloxicam 15 mg Tablets Under Non-Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00840879
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : August 4, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE February 6, 2009
First Posted Date  ICMJE February 10, 2009
Results First Submitted Date  ICMJE June 30, 2009
Results First Posted Date  ICMJE August 4, 2009
Last Update Posted Date September 11, 2009
Study Start Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 96 hour period ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 96 hour period ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 96 hour period ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2009)
Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ]
Change History Complete list of historical versions of study NCT00840879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Meloxicam 15 mg Tablets Under Non-Fasting Conditions
Official Title  ICMJE A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Meloxicam 15 mg Tablets Versus Mobic® 15 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
Brief Summary The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions.
Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Meloxicam 15 mg Tablets
    1 x 15 mg, single-dose fed
  • Drug: Mobic® 15 mg Tablets
    1 x 15 mg, single-dose fed
Study Arms  ICMJE
  • Experimental: Meloxicam
    Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
    Intervention: Drug: Meloxicam 15 mg Tablets
  • Active Comparator: Mobic®
    Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
    Intervention: Drug: Mobic® 15 mg Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2009)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2004
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non tobacco user for at least 90 days prior to pre-study medical).
  • Body mass Index (BMI = weight/height²) greater than or equal to 18.5 kg/m² and less than or equal to 29.9 kg/m².
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
  • Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.5ºC).
  • Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
  • No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
  • Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.

Exclusion Criteria:

  • Known history of hypersensitivity to meloxicam (for example Mobic®), or related drugs such as any other non-steroidal anti-inflammatory drugs (NSAID) such as acetylsalicyclic acid (e.g. Excedrin®, Aspirin®), ibuprofen (e.g. Motrin®), celecoxib (e.g. Celebrex®), Feldene®, Indocin®, Naprosyn®, Vioxx®, Toradol®, Clinoril®, Tolectin®, or Lodine®.
  • Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, or liver disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
  • Any history or presence of peptic ulcer disease, gastrointestinal bleeding, or kidney disease.
  • Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  • Any clinically significant illness during the last four weeks prior to entry into this study.
  • Presence of any significant physical or organ abnormality.
  • Any subject with history of drug abuse.
  • Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
  • Use of any prescription medication within 14 days preceding entry into this study.
  • Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
  • Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
  • Female subjects: presence of pregnancy or lactation.
  • Female subjects at risk of becoming pregnant must consent to using two medically acceptable methods of contraception throughout the entire study, including the washout period and for one month after the completion of the study. Medically acceptable barrier methods of contraception that may be used by the subject and/or partner include diaphragm with spermicide, IUD, condom with foam, and vaginal spermicidal suppository. Complete abstinence can be used alone as a method of contraception.
  • Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR or within the lockout period specified by a previous study conducted at BCR.
  • Participation in a clinical trial with an investigational drug within 30 days preceding this study.
  • Any subject who has donated blood within 56 days preceding this study.
  • Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
  • Any subject with a recent (less than one year) history of alcohol abuse.
  • Significant or recent history of asthma (after 12 years of age), or familial history of asthma or aspirin-sensitive asthma, sever bronchospasm, nasal polyps or chronic sinusitis.
  • Intolerance to venipuncture.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00840879
Other Study ID Numbers  ICMJE 2825
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Teva Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Y. Tam, M.D. Biovail Contract Research
PRS Account Teva Pharmaceuticals USA
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP