Overview

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

Status:
Active, not recruiting
Trial end date:
2023-02-20
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yung Shin Pharm. Ind. Co., Ltd.
Treatments:
Cefoperazone
Sulbactam
Sulperazone
Criteria
Inclusion Criteria:

1. Healthy adult male or female subjects between 20-45 years of age (inclusive) at the
screening visit.

2. Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.

3. 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.

4. 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).

5. 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.

6. 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.

7. Female of childbearing potential practicing an acceptable method of birth control for
the duration of the study.

8. Have signed the written informed consent to participate in the study.

Exclusion Criteria:

1. A clinically significant disorder involving the cardiovascular, respiratory, hepatic,
renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or
neurologic system(s) or psychiatric disease.

2. A clinically significant illness or surgery within four weeks prior to Period I
dosing.

3. 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.

4. History of kidney disease or urination problem over last two years deemed by the
investigator to be clinically significant.

5. Known or suspected history of drug abuse within lifetime.

6. 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).

7. History of allergic response(s) to palonosetron or any other related drugs.

8. Evidence of chronic or acute infectious diseases.

9. Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody
(HCVAb), or human immunodeficiency virus (HIV).

10. Female subjects demonstrating a positive pregnancy screen prior to the study.

11. Female subjects who are currently breastfeeding.

12. 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.

13. Taking any prescription medications within four weeks or any nonprescription
medications (excluding flu vaccination) within two weeks prior to Period I dosing.

14. Use of any investigational drug within four weeks prior to Period I dosing.

15. Use of any COVID-19 vaccine within seven days prior to Period I dosing.

16. 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.

17. Any other medical reason as determined by the investigator.