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

Launched by BOEHRINGER INGELHEIM · Jul 4, 2014

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. Healthy adult male, aged between 20 and 40 years old
• • 3. Body Mass Index (BMI) between 18.5 and 25, inclusive (BMI was calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]).
• • 4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
• • 5. 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.
• • 6. No significant deviation from normal hematology including: hemoglobin, hematocrit, white blood count (WBC) with differential, red blood count (RBC) and platelet count
• • 7. No significant deviation from normal urinalysis including: pH, occult blood, glucose and protein.
• Exclusion Criteria:
• • 1. History of drug or alcohol abuse within the past one year
• • 2. Medical history of allergic asthma or sensitivity to analogous drug
• • 3. Evidence of chronic or acute infectious diseases from 4 weeks before the study
• • 4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
• • 5. Ongoing peptic ulcer and constipation
• • 6. Planned vaccination during the time course of the study.
• • 7. Taking any clinical investigation drug from 3 months before the study
• • 8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study
• • 9. Blood donation of more than 500 ml within the past 3 months
• • 10. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
• • 11. A positive test for HIV antibody