Overview

Meloxicam 15 mg Tablets Under Fasting Conditions

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
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 fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Teva Pharmaceuticals USA
Treatments:
Meloxicam
Criteria
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.