Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Healthy Subjects Clinical Trial

Official title:

Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297968
• Other study ID #: QL-ASTWOS-001
• Status: Completed
• Phase: Phase 1
• Start date: May 13, 2021
• Est. completion date: June 27, 2021

Study information

• Verified date: March 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 27, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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)
• Oseltamivir Phosphate For Oral Suspension
the subjects randomly received single oral administration of Oseltamivir Phosphate For Oral Suspension 75mg (6mg/ml,12.5ml)

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	up to 1 year
Primary	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
Primary	Area under the plasma concentration versus time curve (AUC0-8)	Evaluation of Area under the plasma concentration versus time curve (AUC0-8)	up to 1 year
Primary	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	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	up to 1 year