Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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 fasting conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shirley Ann Kennedy, 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 |
Not provided
| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided