- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654090
Evaluate Bioequivalence of Burotam (1/1 g/Vial)
December 8, 2022 updated by: Yung Shin Pharm. Ind. Co., Ltd.
A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Cefoperazone Sodium and Sulbactam Sodium Combination (1/1 g/Vial) After Intravenous Infusion of 1 g Cefoperazone Sodium and 1 g Sulbactam Sodium in Healthy Volunteers Under Fasting Conditions
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of cefoperazone sodium and sulbactam sodium combination (1/1 g/vial) after intravenous infusion of 1 g cefoperazone sodium and 1 g sulbactam sodium in healthy volunteers under fasting conditions
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
14
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan
- Taichung Veterans General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 18 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
- Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
Acceptable medical history and physical examination including:
- no particular clinically significant abnormalities in ECG results within six months prior to Period I dosing.
- no particular clinical significance in general disease history within two months prior to Period I dosing.
- Acceptable biochemistry determinations (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), γ-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride (TG).
- Acceptable hematology (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes hemoglobin, hematocrit, red blood cell count, white blood cell count with differentials and platelets.
- Acceptable urinalysis (within normal limits or considered by the investigator or physician to be of no clinical significance) within two months prior to Period I dosing, which includes pH, blood, glucose, ketones, bilirubin and protein.
- Female of childbearing potential practicing an acceptable method of birth control for the duration of the study.
- Have signed the written informed consent to participate in the study.
Exclusion Criteria:
- A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
- A clinically significant illness or surgery within four weeks prior to Period I dosing.
- History of gastrointestinal obstruction, inflammatory bowel disease, gallbladder disease, pancreas disorder over last two years or history of gastrointestinal tract surgery over last five years.
- History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
- Known or suspected history of drug abuse within lifetime.
- History of alcohol addiction or abuse within last five years or use of more than 7 units of alcohol per week within two weeks prior to dosing. (1 unit of alcohol = 10 g of alcohol or about 350 mL of beer or about 83 mL of red wine or about 30 mL of beverage containing 40% (v/v) alcohol).
- History of allergic response(s) to palonosetron or any other related drugs.
- Evidence of chronic or acute infectious diseases.
- Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- Female subjects demonstrating a positive pregnancy screen prior to the study.
- Female subjects who are currently breastfeeding.
- Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to Period I dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine.
- Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to Period I dosing.
- Use of any investigational drug within four weeks prior to Period I dosing.
- Use of any COVID-19 vaccine within seven days prior to Period I dosing.
- Donating more than 250 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing.
- Any other medical reason as determined by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cefoperazone sodium and sulbactam sodium (Product name:Burotam)
Single dose cefoperazone sodium and sulbactam sodium 1g/1g
|
Pharmacokinetic study under fasting conditions
|
Active Comparator: cefoperazone sodium and sulbactam sodium (Product name:Brosym)
Single dose cefoperazone sodium and sulbactam sodium 1g/1g
|
Pharmacokinetic study under fasting conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak plasma concentration (Cmax)
Time Frame: 0 (pre-dose), 5, 10 minutes after the start of infusion, immediately after the end of infusion (15 minutes after the start of infusion), and 5, 15, 30, and 45 minutes, and 1.75, 2.75, 3.75, 4.75, 5.75, 7.75, and 11.75 hours after the end of infusion
|
0 (pre-dose), 5, 10 minutes after the start of infusion, immediately after the end of infusion (15 minutes after the start of infusion), and 5, 15, 30, and 45 minutes, and 1.75, 2.75, 3.75, 4.75, 5.75, 7.75, and 11.75 hours after the end of infusion
|
Area under the concentration-time curve from time zero to time of last quantifiable
Time Frame: 0 (pre-dose), 5, 10 minutes after the start of infusion, immediately after the end of infusion (15 minutes after the start of infusion), and 5, 15, 30, and 45 minutes, and 1.75, 2.75, 3.75, 4.75, 5.75, 7.75, and 11.75 hours after the end of infusion
|
0 (pre-dose), 5, 10 minutes after the start of infusion, immediately after the end of infusion (15 minutes after the start of infusion), and 5, 15, 30, and 45 minutes, and 1.75, 2.75, 3.75, 4.75, 5.75, 7.75, and 11.75 hours after the end of infusion
|
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)
Time Frame: 0 (pre-dose), 5, 10 minutes after the start of infusion, immediately after the end of infusion (15 minutes after the start of infusion), and 5, 15, 30, and 45 minutes, and 1.75, 2.75, 3.75, 4.75, 5.75, 7.75, and 11.75 hours after the end of infusion
|
0 (pre-dose), 5, 10 minutes after the start of infusion, immediately after the end of infusion (15 minutes after the start of infusion), and 5, 15, 30, and 45 minutes, and 1.75, 2.75, 3.75, 4.75, 5.75, 7.75, and 11.75 hours after the end of infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2022
Primary Completion (Actual)
November 18, 2022
Study Completion (Anticipated)
February 20, 2023
Study Registration Dates
First Submitted
December 8, 2022
First Submitted That Met QC Criteria
December 8, 2022
First Posted (Actual)
December 16, 2022
Study Record Updates
Last Update Posted (Actual)
December 16, 2022
Last Update Submitted That Met QC Criteria
December 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YSP-RNH3002-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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