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

Yung Shin Pharm. Ind. Co., Ltd.1 site in 1 country16 target enrollmentAugust 17, 2020

ConditionsChemotherapy-induced Nausea and Vomiting, Prophylaxis

InterventionsPalonosetron

DrugsPalonosetron

Overview

Phase: Phase 4
Intervention: Palonosetron
Conditions: Chemotherapy-induced Nausea and Vomiting, Prophylaxis
Sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Enrollment: 16
Locations: 1
Primary Endpoint: Peak concentration (Cmax)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 17, 2020

End Date

December 31, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Yung Shin Pharm. Ind. Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

Palonosetron (Stothu®)

Stothu® Solution for Injection 0.25 mg/5 mL

Intervention: Palonosetron

Palonosetron (Aloxi®)

Aloxi® Solution for Injection 0.25 mg/5mL

Intervention: Palonosetron

Outcomes

Primary Outcomes

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