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The objective of this study is to determine the relative bioavailability of one 15 mg Meloxicam tablet (Dr. Reddy. Laboratories Ltd.,Generics) versus one 15 mg Mobic (meloxicam) Tablet (Boehringer Ingelheim Pharmaceuticals Inc., USA) under fasting conditions.
Twenty eight (twenty six study subjects + two alternate subjects)healthy male and/or female subjects participated in an open label, two-period, two-sequence, two- treatment,single dose, two-way crossover study with at least 14 days washout between doses conducted under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam | Experimental | Meloxicam Tablets 15 mg of Dr.Reddy's Laboratories Limited |
|
| Mobic | Active Comparator | Mobic Tablets 15 mg of Boehringer Ingelheim Pharmaceuticals Inc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug | Meloxicam Tablets 15 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence on Cmax and AUC parameters | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepen M Patel, M.D., C.C.F.P. | Allied Research International Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allied Research International Inc. | Mississauga | Ontario | L4W 1N2 | Canada |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |