Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2021-06-27

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.

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized,two-treatment,two-period,two-sequence

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open

Study Groups

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Oseltamivir Phosphate For Oral Suspension/Tamiflu

Tamiflu ,6mg/ml,batch no.3235821,manufactured by F.Hoffmann-La Roche Ltd.

Group Type ACTIVE_COMPARATOR

Oseltamivir Phosphate For Oral Suspension/Tamiflu

Intervention Type DRUG

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

Oseltamivir Phosphate For Oral Suspension

6mg/ml,batch no.GH1A0003,manufactured by Qilu Pharmaceutical(Hainan) Co., Ltd.

Group Type EXPERIMENTAL

Oseltamivir Phosphate For Oral Suspension

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Oseltamivir Phosphate For Oral Suspension

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

Intervention Type DRUG

Other Intervention Names

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tamiflu

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes