Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
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:
|
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)
|
Outcome Measures
Primary Outcome Measures
- Peak Plasma Concentration (Cmax) [up to 1 year]
Evaluation of Peak Plasma Concentration (Cmax)
- Area under the plasma concentration versus time curve (AUC0-t) [up to 1 year]
Evaluation of Area under the plasma concentration versus time curve (AUC0-t)
- Area under the plasma concentration versus time curve (AUC0-∞) [up to 1 year]
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
- Bioequivalence [up to 1 year]
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%
Secondary Outcome Measures
- Incidence of Treatment-Emergent Adverse Events [up to 1 year]
Collection of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Phase I Clinical Research Center | Qingdao | Shandong | China | 266003 |
Sponsors and Collaborators
- The Affiliated Hospital of Qingdao University
Investigators
- Principal Investigator: yu Cao, Dr, the study director of phase I clinical research center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL-ASTWOS-001