Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

an open label,balanced,randomized,two-treatment,two-period,two-sequence,single dose,crossover,oral bioequivalence Study of oseltamivir phosphate for oral suspension in healthy ,adult,human subjects under fasted/fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu; Drug: Oseltamivir Phosphate For Oral Suspension

Detailed Description

72 healthy adult subjects will be enrolled and randomized in the study.In each period,total 21 venous blood samples (3ml each)will be collected at 0h，10min,20min,30min,45min,1h,1.25h,1.5h,1.75h,2h,2.25h,2.5h,3h,3.5h,4h,4.5h,5h,6h,8h,12h,24h,36h.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1) Subjects are able to give the signed ICF before the study, and fully understand the study content, process and possible adverse reactions; 2) Subjects are able to complete the study in compliance the study in compliance with the protocol; 3) Subjects (including male subjects) agree to adopt effective contraceptive methods and not plan to get pregnant or to donate sperm or ovum from 14 days before screening to 3 months after study completion; 4) Healthy male and female subjects above 18 years of age ( inclusive); 5) Male subjects who are at least 50 kg and female subjects who are at least 45 kg, with a Body Mass Index (BMI)= Weight/Height2 (kg/m2) between 19.0-26.0 kg/m2 (both inclusive);

Exclusion Criteria:

1. History of specific allergies (asthma, etc.), allergies (such as those who are allergic to two or more drugs, foods such as milk or pollen), or hypersensitivity to Oseltamivir Phosphate or any excipients or related class of drugs
2. People with rare hereditary galactose intolerance or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency;
3. No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.;
4. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption;
5. History of surgery within 3 months prior to first dosing;
6. 5 or more cigarettes per day on average within 3 months before the screening;
7. Use of any drugs within 14 days prior to dosing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oseltamivir Phosphate For Oral Suspension/Tamiflu; Tamiflu ,6mg/ml,batch no.3235821,manufactured by F.Hoffmann-La Roche Ltd.	Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu; the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension/Tamiflu 75mg (6mg/ml,12.5ml); Other Names: tamiflu
EXPERIMENTAL: Oseltamivir Phosphate For Oral Suspension; 6mg/ml,batch no.GH1A0003,manufactured by Qilu Pharmaceutical(Hainan) Co., Ltd.	Drug: Oseltamivir Phosphate For Oral Suspension; the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension 75mg (6mg/ml,12.5ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	up to 1 year
Area under the plasma concentration versus time curve (AUC0-t)	Evaluation of Area under the plasma concentration versus time curve (AUC0-t)	up to 1 year
Area under the plasma concentration versus time curve (AUC0-∞)	Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)	up to 1 year
Bioequivalence	Analysis of variance (ANOVA) was performed after logarithmic conversion of main pharmacokinetic parameters (Cmax, AUC) to calculate 90% confidence interval of geometric mean ratio of main pharmacokinetic parameters of the two preparations, and equivalence comparison was conducted. The equivalent interval was set to 80.00%~125.00%	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	up to 1 year

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University
• Investigators: Principal Investigator: yu Cao, Dr, the study director of phase I clinical research center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 13, 2021
• Primary Completion (ACTUAL): June 6, 2021
• Study Completion (ACTUAL): June 27, 2021

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (ACTUAL): March 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: QL-ASTWOS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No