Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

Sponsor
The Affiliated Hospital of Qingdao University (Other)
Overall Status
Completed
CT.gov ID
NCT05297968
Collaborator
(none)
72
1
2
1.5
48.7

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
  • Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu
  • Drug: Oseltamivir Phosphate For Oral Suspension
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

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomized,two-treatment,two-period,two-sequencerandomized,two-treatment,two-period,two-sequence
Masking:
None (Open Label)
Masking Description:
open
Primary Purpose:
Treatment
Official Title:
Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension
Actual Study Start Date :
May 13, 2021
Actual Primary Completion Date :
Jun 6, 2021
Actual Study Completion Date :
Jun 27, 2021

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:
  • tamiflu
  • 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

    1. Peak Plasma Concentration (Cmax) [up to 1 year]

      Evaluation of Peak Plasma Concentration (Cmax)

    2. 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)

    3. Area under the plasma concentration versus time curve (AUC0-∞) [up to 1 year]

      Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)

    4. 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

    1. Incidence of Treatment-Emergent Adverse Events [up to 1 year]

      Collection of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    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.
    Responsible Party:
    The Affiliated Hospital of Qingdao University
    ClinicalTrials.gov Identifier:
    NCT05297968
    Other Study ID Numbers:
    • QL-ASTWOS-001
    First Posted:
    Mar 28, 2022
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 28, 2022