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OpenTrials
Completed

NCT Number: NCT02183181

Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers

Primary Objective:

To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg (Reference, R) following oral administration.

Secondary Objective:

To investigate the safety and tolerability of meloxicam following a single dose of meloxicam capsule 15 mg vs. meloxicam tablet 15 mg under fasting conditions in healthy male Taiwanese subjects.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed written informed consent before enrolment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study
  • Healthy adult male, aged between 20 and 40 years old
  • Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram [kg]/height in meters2 [m2]).
  • Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
  • No significant deviation from biochemistry including: aspartate transaminase (SGOT/AST), alanine transaminase (SGPT/ALT), gamma-glutamyl-transferase (GGT), alkaline phosphatase, total bilirubin, albumin, glucose, blood urea nitrogen (BUN), creatinine, uric acid, total cholesterol and triglyceride.
  • No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
  • No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.

Exclusion criteria

  • History of drug or alcohol abuse within the past one year
  • Medical history of allergic asthma or sensitivity to analogous drug
  • Evidence of chronic or acute infectious diseases from 4 weeks before the study
  • Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
  • Ongoing peptic ulcer and constipation
  • Planned vaccination during the time course of the study.
  • Taking any clinical investigation drug from 3 months before the study
  • Use of any medication, including herb medicine or vitamins from 4 weeks before the study
  • Blood donation of more than 500 ml within the past 3 months
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
  • A positive test for HIV antibody

Treatment and study plan

Meloxicam capsule

Drug

Meloxicam tablet

Drug

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval zero to infinity (AUC0-infinity)

    Time frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration

  2. Area under the plasma concentration-time curve from 0 h to last concentration time (AUC0-tz)

    Time frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration

  3. Observed maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration

  4. Time to reach maximum plasma concentration (Tmax)

    Time frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration

  5. Plasma half-life estimated by (0.693/ kel) ( t ½)

    Time frame: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 48, 72 and 96 hours after administration

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: up to 33 days after first administration

  2. Drug induced changes in standard laboratory values

    Time frame: screening phase (at least 10hours fasting), before and 24 h following drug administration on each study day, within 14 days after completion of all two periods

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Single-dose, Two-way Crossover Study to Assess the Bioequivalence of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) Administered to Healthy Adult Volunteers

Important dates

Study start
2008
Primary completion
2009
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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