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Evaluate Bioequivalence of Burotam (1/1 g/Vial)

Primary Purpose

Infectious Diseases

Status
Active
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
cefoperazone sodium and sulbactam sodium
Sponsored by
Yung Shin Pharm. Ind. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infectious Diseases

Eligibility Criteria

20 Years - 20 Years (Adult)Accepts Healthy Volunteers

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.

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cefoperazone sodium and sulbactam sodium (Product name:Burotam)

cefoperazone sodium and sulbactam sodium (Product name:Brosym)

Arm Description

Single dose Burotam

Single dose Brosym

Outcomes

Primary Outcome Measures

Peak plasma concentration (Cmax)
Area under the concentration-time curve from time zero to time of last quantifiable
Area under the concentration-time curve from time zero to infinity (AUC 0-∞)

Secondary Outcome Measures

Full Information

First Posted
December 8, 2022
Last Updated
January 29, 2023
Sponsor
Yung Shin Pharm. Ind. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05654090
Brief Title
Evaluate Bioequivalence of Burotam (1/1 g/Vial)
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
February 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yung Shin Pharm. Ind. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
An open-label, randomized, balanced, two-treatment, two-period, twosequence, single dose, two-way crossover study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cefoperazone sodium and sulbactam sodium (Product name:Burotam)
Arm Type
Experimental
Arm Description
Single dose Burotam
Arm Title
cefoperazone sodium and sulbactam sodium (Product name:Brosym)
Arm Type
Active Comparator
Arm Description
Single dose Brosym
Intervention Type
Drug
Intervention Name(s)
cefoperazone sodium and sulbactam sodium
Intervention Description
Pharmacokinetic study under fasting conditions
Primary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluate Bioequivalence of Burotam (1/1 g/Vial)

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