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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Meloxicam capsule; Drug: Meloxicam tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183181

107.274

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Meloxicam capsule

Experimental group

Description:

Capsules 15 mg

Treatment:

Drug: Meloxicam capsule

Meloxicam tablet

Active Comparator group

Description:

Tablets 15 mg

Treatment:

Drug: Meloxicam tablet