Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Qingdao University

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu; Drug: Oseltamivir Phosphate For Oral Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT05297968

QL-ASTWOS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Oseltamivir Phosphate For Oral Suspension/Tamiflu

Active Comparator group

Description:

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

Treatment:

Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu

Oseltamivir Phosphate For Oral Suspension

Experimental group

Description:

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

Treatment:

Drug: Oseltamivir Phosphate For Oral Suspension