Evaluate Bioequivalence of Palonosetron (0.25mg/5mL) (NCT04585412) | Clinical Trial Compass
CompletedPhase 4
Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
Taiwan16 participantsStarted 2020-08-17
Plain-language 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.
Who can participate
Age range20 Years β 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Healthy adult male or female subjects between 20-45 years of age (inclusive) at the screening visit.
β. Body mass index (BMI) between 18 and 27 kg/m2 (not inclusive) at the screening visit.
β. Acceptable medical history and physical examination including:
β. 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), Ξ³-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol and triglyceride (TG).
β. 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.
β. 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.
β. Female of childbearing potential practicing an acceptable method of birth control for the duration of the study.
β. Have signed the written informed consent to participate in the study.
Exclusion criteria
β. A clinically significant disorder involving the cardiovascular, respiratory, hepatic, renal, urinary tract, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease.
β. A clinically significant illness or surgery within four weeks prior to Period I dosing.
β. 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.
β. History of kidney disease or urination problem over last two years deemed by the investigator to be clinically significant.
β. Known or suspected history of drug abuse within lifetime.
β. 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).
β. History of allergic response(s) to palonosetron or any other related drugs.
β. Evidence of chronic or acute infectious diseases.
What they're measuring
1
Peak concentration (Cmax)
Timeframe: 0 (pre-dose), β€2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
2
Time to reach peak concentration (Tmax)
Timeframe: 0 (pre-dose), β€2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
3
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)
Timeframe: 0 (pre-dose), β€2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
4
Area under the concentration-time curve from time zero to infinity (AUC0-β)
Timeframe: 0 (pre-dose), β€2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
5
Elimination rate constant (ε ₯z)
Timeframe: 0 (pre-dose), β€2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose
6
Terminal elimination half-life (t1/2)
Timeframe: 0 (pre-dose), β€2, 5, 15, and 30 minutes, and 1, 2, 4, 6, 12, 24, 48, 72, 96, 120, 144, and 168 hours post dose