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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00550329 |
Purpose
The objective of this study is to determine the bioequivalence of Glipizide GITS (Glucotrol XL) 2.5 mg tablets manufactured at the Brooklyn, New York facility versus tablets manufactured at the facility in Barceloneta, Puerto Rico.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent Hyperglycemia |
Drug: Glipizide GITS |
Phase I |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of Glucotrol XL 2.5 Mg Tablets Manufactured At Brooklyn, New York Versus At Barceloneta, Puerto Rico In Healthy Subjects |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | A1251009 |
| Study First Received: | October 26, 2007 |
| Last Updated: | October 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00550329 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypoglycemic Agents Glipizide Metabolic Diseases Hyperglycemia Physiological Effects of Drugs |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |