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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649662 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin extended-release 1000 mg tablets to Bayer's Cipro® XR 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Ciprofloxacin Extended-Release Tablets 1000 mg Drug: Cipro® XR Tablets 1000 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Ciprofloxacin Extended-Release Tablets (1000 mg; Mylan) and Cipro® XR Tablets (1000 mg; Bayer) in Healthy Volunteers |
| Enrollment: | 36 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Ciprofloxacin Extended-Release Tablets 1000 mg
|
Drug: Ciprofloxacin Extended-Release Tablets 1000 mg
1000mg, single dose fasting
|
|
2: Active Comparator
Cipro® XR Tablets 1000 mg
|
Drug: Cipro® XR Tablets 1000 mg
1000mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women must practice abstinence or use an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | CIPR-04105 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649662 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Infective Agents Ciprofloxacin Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Pharmacologic Actions Nucleic Acid Synthesis Inhibitors |