Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product

NCT05083325 | Completed Phase 1

• 1 other identifier: HP8835-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the bioavailability in fasting male and/or non-pregnant and non- breast feeding female subjects of 1 capsule formulation containing Oseltamivir Phosphate 75 mg. The study will be performed at a single site with 36 subjects. Participants will take 1 capsule of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 2 days between each study period.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (4)

• Total Oseltamivir Phosphate: area under the plasma concentration-time curve from 0 to time t (AUC0-t)

  20 samples up to 10 hours will be taken after the administration in each period.

• Total Oseltamivir Phosphate: area under the plasma concentration-time curve from 0 to time infinite (AUC0-∞)

  20 samples up to 10 hours will be taken after the administration in each period.

• Total Oseltamivir Phosphate: Maximum plasma concentration (Cmax)

  20 samples up to 10 hours will be taken after the administration in each period.

• Total Oseltamivir Phosphate: Time to achieve maximum plasma concentration (tmax)

  20 samples up to 10 hours will be taken after the administration in each period.

Study Arms (2)

Oseltamivir Phosphate Test Product

EXPERIMENTAL

Participants will receive one capsule of the test formulation containing Oseltamivir 75 mg. The capsules will be taken with water and in a fasting condition.

Drug: Oseltamivir 75mg Test Drug capsules

Oseltamivir Phosphate Referent Product

ACTIVE COMPARATOR

Participants will receive one capsule of the marketed reference containing Oseltamivir 75 mg. The capsules will be taken with water and in a fasting condition.

Drug: Oseltamivir 75mg capsules Reference Product capsules

Interventions

Oseltamivir 75mg Test Drug capsules DRUG

Investigational Medicinal Product

Oseltamivir Phosphate Test Product

Oseltamivir 75mg capsules Reference Product capsules DRUG

Tamiflu (Roche Pharma (Switzerland) AG, Basel)

Oseltamivir Phosphate Referent Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg.
• Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• Normal or clinically insignificant ECG.
• Negative urine test for drugs of abuse for both males and females and negative pregnancy test for females and do not plan to become pregnant during course of the study and for 03 months after completion of study.
• Volunteers who are willing to use acceptable methods of contraception (barrier method/IUD/surgical) or abstinence, for the entire duration of the study and do not plan to be pregnant for at least 1 month after the last drug administration.
• Volunteers who can give written informed consent and communicate effectively.

You may not qualify if:

• History of any major surgical procedure in the past 03 months.
• History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• History of chronic alcoholism/ chronic smoking/ drug of abuse.
• Volunteers with known hypersensitivity to Oseltamivir phosphate or any of the excipients.
• History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
• Volunteers who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Oseltamivir phosphate or any other medication judged to be clinically significant by the investigator.
• History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• History of consumption of one or more of the below, 48 hours prior to dosing:
• Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator
• Volunteers who are dysphagic.

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Azidus Laboratories Ltd.

Chennai, Tamil Nadu, 600048, India

Location

MeSH Terms

Interventions

Oseltamivir; Drug Evaluation

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: October 8, 2021
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)