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The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation in healthy, adult, non-smoking subjects under non-fasting conditions.
This single dose, randomized, two-period, two-treatment, two sequence crossover study was conducted to compare the relative bioavailability of ciprofloxacin 1000 mg ER tablets of Dr. Reddy's and CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation under non-fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Experimental | Ciprofloxacin Extended Release Tablets of Dr. Reddy's Laboratories Limited |
|
| CIPRO®XR | Active Comparator | CIPRO® XR (Bayer Health Care, Bayer Pharmaceuticals Corporation) Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIPRO®XR | Drug | Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence on Cmax and AUC parameters | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saran Hong, M.D. | Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, United States of America (USA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVUM Pharmaceutical Research Services | Houston | Texas | 77042 | United States |
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| ID | Term |
|---|---|
| D007863 | Lecithin Cholesterol Acyltransferase Deficiency |
| ID | Term |
|---|---|
| D052456 | Hypoalphalipoproteinemias |
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
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| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |