Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product
NCT ID: NCT05083325
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2021-10-08
2021-10-10
Brief Summary
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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.
Detailed Description
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* Test Product: Product manufactured by Laboratorios Silesia S.A.
* Reference Product: Tamiflu \[Trademark\], product of Roche Pharma AG, Switzerland.
The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to infinite (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Oseltamivir Phosphate will be determined. Participants will be confined in the study site for approximately 68 hours during the entire study (for 10 hours pre-dosing and for 10 hours post dosing in period II) during which pharmacokinetic (PK) blood samples will be obtained. 20 blood samples will be taken up to 10 hours after the administration in each period.
The washout period between the two study periods will be at least 2 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Oseltamivir in plasma.
The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Oseltamivir Phosphate Test Product
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.
Oseltamivir 75mg Test Drug capsules
Investigational Medicinal Product
Oseltamivir Phosphate Referent Product
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.
Oseltamivir 75mg capsules Reference Product capsules
Tamiflu (Roche Pharma (Switzerland) AG, Basel)
Interventions
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Oseltamivir 75mg Test Drug capsules
Investigational Medicinal Product
Oseltamivir 75mg capsules Reference Product capsules
Tamiflu (Roche Pharma (Switzerland) AG, Basel)
Eligibility Criteria
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Inclusion Criteria
2. Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
3. Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
4. Normal or clinically insignificant ECG.
5. 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.
6. 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.
7. Volunteers who can give written informed consent and communicate effectively.
Exclusion Criteria
2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
3. History of chronic alcoholism/ chronic smoking/ drug of abuse.
4. Volunteers with known hypersensitivity to Oseltamivir phosphate or any of the excipients.
5. History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
6. Volunteers who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
7. 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.
8. History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
9. Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
10. 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
11. Volunteers who are dysphagic.
18 Years
45 Years
ALL
Yes
Sponsors
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Laboratorios Andromaco S.A.
INDUSTRY
Responsible Party
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Locations
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Azidus Laboratories Ltd.
Chennai, Tamil Nadu, India
Countries
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Other Identifiers
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HP8835-01
Identifier Type: -
Identifier Source: org_study_id