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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions

NCT01136525

Healthy

COMPLETED PHASE1

BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis

NCT00670215

Bacterial Infections

COMPLETED PHASE3

Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers

NCT02442310

Healthy

COMPLETED PHASE1

Bioavailability Study of K0706 in Healthy Subjects

NCT03316820

Healthy

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects

NCT03135509

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fasting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ciprofloxacin

Ciprofloxacin Extended Release Tablets of Dr. Reddy's Laboratories Limited

Group Type EXPERIMENTAL

CIPRO®XR

Intervention Type DRUG

Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited

CIPRO®XR

CIPRO® XR (Bayer Health Care, Bayer Pharmaceuticals Corporation) Tablets

Group Type ACTIVE_COMPARATOR

CIPRO®XR

Intervention Type DRUG

Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CIPRO®XR

Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CIPRO®XR tablets of Bayer Health Care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes