Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01372345
First received: January 27, 2011
Last updated: June 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Fasting
Drug: CIPRO®XR
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose, Randomized, Two-period, Two-treatment, Two-sequence Crossover Relative Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets Under Fasting Condition

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: February 2005
Study Completion Date: March 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin
Ciprofloxacin Extended Release Tablets of Dr. Reddy's Laboratories Limited
Drug: CIPRO®XR
Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
Other Name: CIPRO®XR tablets of Bayer Health Care
Active Comparator: CIPRO®XR
CIPRO® XR (Bayer Health Care, Bayer Pharmaceuticals Corporation) Tablets
Drug: CIPRO®XR
Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
Other Name: CIPRO®XR tablets of Bayer Health Care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Non-institutionalized subjects consisting of members of, the coInmunity at large.
  2. All subjects selected for this study will be non-smokers between 18 and 45 years of age (inclusive). Female subjects must be unable to become pregnant (postmenopausal for at least 1 year, or surgically sterile)
  3. Each subject shall be given, a general physical examination within 28 days of initiation of the study and will include, but is not limited to, blood pressure, general observations, and history.
  4. Each female subject will be given a serum pregnancy test as part of the pre-study screening process.
  5. Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.
  6. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria:

  1. Subjects with a history of alcoholism or drug addiction (during past 2 years), or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  2. Subjects whose clinical laboratory test values are outside the normal range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  3. Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
  4. All subjects will have urine / saliva samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at check-in each dosing period. Subjects found to have urine/saliva concentrations of any of the tested drugs will not be allowed to participate.
  5. Subjects should not have donated blood and / or plasma for at least thirty (30) days prior to tile first dosing of the study.
  6. Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  7. Female subjects who are pregnant or who are able (women with childbearing potential) to become pregnant during the study will not be allowed to participate.
  8. All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  9. Subjects who have a history of clinically significant illnesses or surgery within 4 weeks prior to the administration of the study medication will not be eligible for this study.
  10. Subjects who have a BMI ≥30.0 Kg/m2 will not be eligible for this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372345

Locations
United States, Texas
NOVUM Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Shirley Ann Kennedy, M.D. Novum Pharmaceutical Research Services, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, United States of America (USA)
  More Information

No publications provided

Responsible Party: M.S. Mohan/Vice President- Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01372345     History of Changes
Other Study ID Numbers: B045907
Study First Received: January 27, 2011
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014