Chemotherapy-induced Nausea and Vomiting, ProphylaxisPhase 4NCT04585412
Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
A Phase 4 study testing Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, Prophylaxis, 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 palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting, Prophylaxis
- What is being tested?
- Palonosetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2020to 31 Dec 2020
- 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 45 years
- All sexes
- 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.
- 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 Palonosetron After Intravenous Administration of Palonosetron in Healthy Volunteers Under Fasting Conditions
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.
- Being tested
- Palonosetron
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Also called Stothu®
Pharmacokinetic study under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron (Stothu®) | Experimental | Stothu® Solution for Injection 0.25 mg/5 mL Receives: Drug: Palonosetron |
| Palonosetron (Aloxi®) | Active comparator | Aloxi® Solution for Injection 0.25 mg/5mL Receives: Drug: Palonosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Time to reach peak concentration (Tmax)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Elimination rate constant (入z)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Terminal elimination half-life (t1/2)
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Ratio of AUC0-t to AUC0-∞
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Measured: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start17 Aug 2020
- Primary completion24 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and Vomiting, ProphylaxisStudies 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
- 16 participants (actual)
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
- NCT04585412
- Sponsor's protocol ID
- YSP-RLH3001-01
- Status last verified
- Jul 2021
- First submitted
- 6 Oct 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. 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 Palonosetron After Intravenous Administration of Palonosetron in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04585412
- Acronym / sponsor ID
- YSP-RLH3001-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yung Shin Pharm. Ind. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Oct 2020 (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 palonosetron after intravenous administration of palonosetron 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 |
|---|---|---|
| Palonosetron (Stothu®) | Experimental | Drug: PalonosetronStothu® Solution for Injection 0.25 mg/5 mL |
| Palonosetron (Aloxi®) | Active comparator | Drug: PalonosetronAloxi® Solution for Injection 0.25 mg/5mL |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- 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 (16 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 |
|---|---|---|
| PalonosetronAlso: Stothu®Pharmacokinetic study under fasting conditions | Drug | Palonosetron (Aloxi®), Palonosetron (Stothu®) |
Primary outcome
Peak concentration (Cmax)
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Time to reach peak concentration (Tmax)
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Area under the concentration-time curve from time zero to infinity (AUC0-∞)
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Elimination rate constant (入z)
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Terminal elimination half-life (t1/2)
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Ratio of AUC0-t to AUC0-∞
Time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
The two-sided 90% confidence interval for the difference of means in natural log-transformed Cmax, AUC0-t and AUC0-∞ between test and reference drug will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
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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 Palonosetron in people with Chemotherapy-induced Nausea and Vomiting, Prophylaxis, 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 16 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: finished, as of the sponsor's last update on 4 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 concentration (Cmax) (time frame: 0 (pre-dose), ≤2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose). The study lists 7 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 4 Aug 2021.