Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Palonosetron (Stothu®) Stothu® Solution for Injection 0.25 mg/5 mL |
Drug: Palonosetron
Pharmacokinetic study under fasting conditions
Other Names:
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| Active Comparator: Palonosetron (Aloxi®) Aloxi® Solution for Injection 0.25 mg/5mL |
Drug: Palonosetron
Pharmacokinetic study under fasting conditions
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Peak concentration (Cmax) [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) [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) [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-∞) [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) [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) [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-∞ [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
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Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
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Acceptable medical history and physical examination including:
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no particular clinically significant abnormalities in ECG results within six months prior to Period I dosing.
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no particular clinical significance in general disease history within two months prior to Period I dosing.
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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.
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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.
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Female of childbearing potential practicing an acceptable method of birth control for the duration of the study.
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Have signed the written informed consent to participate in the study.
Exclusion Criteria:
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A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
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A clinically significant illness or surgery within four weeks prior to Period I dosing.
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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.
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History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
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Known or suspected history of drug abuse within lifetime.
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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.
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Evidence of chronic or acute infectious diseases.
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Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
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Female subjects demonstrating a positive pregnancy screen prior to the study.
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Female subjects who are currently breastfeeding.
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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.
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Taking any prescription medications within four weeks or any nonprescription medications (excluding flu vaccination) within two weeks prior to Period I dosing.
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Use of any investigational drug within four weeks prior to Period I dosing.
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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.
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Any other medical reason as determined by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taichung Veterans General Hospital | Taichung | Taiwan |
Sponsors and Collaborators
- Yung Shin Pharm. Ind. Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YSP-RLH3001-01