Study on the Human Bioequivalence of Oseltamivir Phosphate For Oral Suspension

NCT05297968 | Completed Phase 1 DMC

• 1 other identifier: QL-ASTWOS-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  up to 1 year

Study Arms (2)

Oseltamivir Phosphate For Oral Suspension/Tamiflu

ACTIVE COMPARATOR

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

Drug: Oseltamivir Phosphate For Oral Suspension/Tamiflu

Oseltamivir Phosphate For Oral Suspension

EXPERIMENTAL

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

Drug: Oseltamivir Phosphate For Oral Suspension

Interventions

Oseltamivir Phosphate For Oral Suspension/Tamiflu DRUG

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

Also known as: tamiflu

Oseltamivir Phosphate For Oral Suspension/Tamiflu

Oseltamivir Phosphate For Oral Suspension DRUG

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

Oseltamivir Phosphate For Oral Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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);

You may not qualify if:

• 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;
• or more cigarettes per day on average within 3 months before the screening;
• Use of any drugs within 14 days prior to dosing

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Interventions

Oseltamivir; Suspensions

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• yu Cao, Dr

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized,two-treatment,two-period,two-sequence

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 28, 2022
• Study Start: May 13, 2021
• Primary Completion: June 6, 2021
• Study Completion: June 27, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)