Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas
Completed
Bayer
Phase 4
2004-05-01
Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can
help people with a complicated urinary tract infection caused by a kind of bacteria called
Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is
safe and works to treat complicated urinary tract infections caused by Pseudomonas
aeruginosa. The study doctor will also gather information about using Cipro XR to treat
complicated urinary tract infections caused by other bacteria. About 500 people with
complicated urinary tract infections who are 18 years old and older will join this study.
Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of
complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of
the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has
been shown to be safe and effective. This study is being done to gather more information on
using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas
aeruginosa, as well as by other bacteria.
Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mg
Completed
Mylan Pharmaceuticals
Phase 1
2005-11-01
The objective of this study was to investigate the bioequivalence of Mylan's ciprofloxacin
extended-release 500 mg tablets to Bayer's Cipro® XR 500 mg tablets following a single, oral
500 mg (1 x 500 mg) dose administered under fasting conditions.
Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
Completed
Mylan Pharmaceuticals
Phase 1
2005-10-01
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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
