Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu
* Drug: Oseltamivir Phosphate For Oral Suspension


Participation Criteria
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Eligibility Criteria
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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: 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 People with rare hereditary galactose intolerance or fructose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency; No history of cardiac, hepatic, renal, digestive tract, nervous system, mental and metabolic disorders, etc.; History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption; History of surgery within 3 months prior to first dosing; 5 or more cigarettes per day on average within 3 months before the screening; Use of any drugs within 14 days prior to dosing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized,two-treatment,two-period,two-sequence
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |