Infectious DiseasesPhase 4NCT05654090
Evaluate Bioequivalence of Burotam (1/1 g/Vial)
A Phase 4 study testing cefoperazone sodium and sulbactam sodium in people with Infectious Diseases, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- cefoperazone sodium and sulbactam sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Aug 2022to 20 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 20 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Infectious Diseases
- Being tested
- cefoperazone sodium and sulbactam sodium
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefoperazone sodium and sulbactam sodiumDrug
Pharmacokinetic study under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| cefoperazone sodium and sulbactam sodium (Product name:Burotam) | Experimental | Single dose Burotam Receives: Drug: cefoperazone sodium and sulbactam sodium |
| cefoperazone sodium and sulbactam sodium (Product name:Brosym) | Active comparator | Single dose Brosym Receives: Drug: cefoperazone sodium and sulbactam sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Measured: 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
Measured: 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-∞)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start25 Aug 2022
- Primary completion18 Nov 2022
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An open-label, randomized, balanced, two-treatment, two-period, twosequence, single dose, two-way crossover study
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654090
- Sponsor's protocol ID
- YSP-RNH3002-01
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05654090
- Acronym / sponsor ID
- YSP-RNH3002-01
- Conditions
- Infectious Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, randomized, balanced, two-treatment, two-period, twosequence, single dose, two-way crossover study
| Arm | Type | Receives |
|---|---|---|
| cefoperazone sodium and sulbactam sodium (Product name:Burotam) | Experimental | Drug: cefoperazone sodium and sulbactam sodiumSingle dose Burotam |
| cefoperazone sodium and sulbactam sodium (Product name:Brosym) | Active comparator | Drug: cefoperazone sodium and sulbactam sodiumSingle dose Brosym |
Who may qualify
- Ages
- 20 to 20 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefoperazone sodium and sulbactam sodiumPharmacokinetic study under fasting conditions | Drug | cefoperazone sodium and sulbactam sodium (Product name:Brosym), cefoperazone sodium and sulbactam sodium (Product name:Burotam) |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefoperazone sodium and sulbactam sodium in people with Infectious Diseases, run by Yung Shin Pharm. Ind. Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.