Meloxicam 15 mg Tablets Under Non-Fasting Conditions

NCT00840879 | Completed Phase 1 Results

• 1 other identifier: 2825
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 96 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  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)

  Bioequivalence based on AUC0-t

  Blood samples collected over 96 hour period

Study Arms (2)

Meloxicam

EXPERIMENTAL

Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period

Drug: Meloxicam 15 mg Tablets

Mobic®

ACTIVE COMPARATOR

Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period

Drug: Mobic® 15 mg Tablets

Interventions

Meloxicam 15 mg Tablets DRUG

1 x 15 mg, single-dose fed

Meloxicam

Mobic® 15 mg Tablets DRUG

1 x 15 mg, single-dose fed

Mobic®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Biovail Contract Research

Toronto, Ontario, M1L4S4, Canada

Location

MeSH Terms

Interventions

Meloxicam

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Paul Y. Tam, M.D.

  Biovail Contract Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: February 1, 2004
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: August 19, 2024
• Results First Posted: August 4, 2009

Record last verified: 2024-08

Locations

CA (1)