BioequivalencePhase 4NCT04536415
Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers
A Phase 4 study testing Oseltamivir Phosphate 75 mg capsules and Tamiflu capsules 75 mg in people with Bioequivalence, run by Austarpharma, LLC at 1 site in United States.
Trial summary
This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Oseltamivir Phosphate 75 mg capsules and Tamiflu capsules 75 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 27 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects' weight within normal range according to normal values for Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
- Subjects with Hemoglobin level ≥ 11.5 G% at the time of screening.
- Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
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- Subjects having negative alcohol breath test or urine alcohol test.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- For Male Subjects: Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide ,Condom with diaphragm , or abstinence, subjects should also not donate sperm during this time.
- Subjects having negative urine pregnancy test at screening and negative Serum β-hCG pregnancy test on admission day of period 01 (only for female subjects).
- For Female Subjects: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), or abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam; or Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above; Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Who cannot join
- Hypersensitivity to Oseltamivir or related class of drugs or any of its excipients or to heparin.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing of period 01.
- Presence of significant alcoholism or drug abuse.
- History or presence of significant smoking (more than 10 cigarettes or beedis/day).
- History or presence of asthma, urticaria or other significant allergic reactions.
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- History or presence of significant gastric and/or duodenal ulceration or gastrointestinal (GI) bleeding.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer or basal or squamous cell carcinoma.
- Difficulty with donating blood.
- Difficulty in swallowing solids like tablets or capsules.
- Use of any prescribed medication or OTC medication within 30 days prior to dosing in period 01.
- Major illness within past 3 months.
- Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
- Consumption of xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing of period 01.
- Consumption of grapefruit or grapefruit juice containing products within 72 hours prior to dosing of period 01.
- Positive screening test result for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- Female subjects who are currently breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Oseltamivir Phosphate 75 mg Capsule of Yangtze River Pharmaceutical (Group) Co., Ltd., China and TAMIFLU® (Oseltamivir Phosphate) Capsules 75 mg of Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 in Healthy, Adult, Human Subjects Under Fed Condition
This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition.
- Conditions
- Bioequivalence
- Being tested
- Oseltamivir Phosphate 75 mg capsules, Tamiflu capsules 75 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir Phosphate 75 mg capsulesDrug
Capsules, 75 mg, single, oral dose
Tamiflu capsules 75 mgDrug
Capsules, 75 mg, single, oral dose
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir Phosphate 75 mg capsules (Yangtze River) | Experimental | During the study session, healthy participants will be administered a single dose of Oseltamivir Phosphate capsules 75 mg of Yangtze River Pharmaceutical (Group) Co., Ltd., China under Fed condition. Receives: Drug: Oseltamivir Phosphate 75 mg capsules |
| Tamiflu capsules 75 mg (Genentech, Inc.) | Active comparator | During the study session, healthy participants will be administered a single dose of Tamiflu capsules 75 mg of Genentech, Inc. under Fed condition. Receives: Drug: Tamiflu capsules 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax)
Maximum measured concentration over the time span specified
Measured: 48 hours
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
The area under the concentration versus time curve, from time 0 to the last measurable concentration, where t = time of last measurable concentration, calculated using linear trapezoidal method
Measured: 48 hours
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC)
The area under the concentration versus time curve from time 0 to infinity AUC0-∞ = AUC0-t + Clast/Kel; where Clast is last measurable concentration, Kel is elimination rate constant.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start25 Aug 2020
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austarpharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tejas Talati, MBBS, Principal investigator, Veeda Clinical Research Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536415
- Sponsor's protocol ID
- 20-VIN-0051
- Status last verified
- Feb 2023
- First submitted
- 28 Aug 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Oseltamivir Phosphate 75 mg Capsule of Yangtze River Pharmaceutical (Group) Co., Ltd., China and TAMIFLU® (Oseltamivir Phosphate) Capsules 75 mg of Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990 in Healthy, Adult, Human Subjects Under Fed Condition
- ClinicalTrials.gov ID
- NCT04536415
- Acronym / sponsor ID
- 20-VIN-0051
- Conditions
- Bioequivalence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Austarpharma, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the bioequivalence of Oseltamivir Phosphate Capsules 75 mg versus TAMIFLU 75 mg capsules administered as 75 mg capsules in healthy volunteers under Fed condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir Phosphate 75 mg capsules (Yangtze River) | Experimental | Drug: Oseltamivir Phosphate 75 mg capsulesDuring the study session, healthy participants will be administered a single dose of Oseltamivir Phosphate capsules 75 mg of Yangtze River Pharmaceutical (Group) Co., Ltd., China under Fed condition. |
| Tamiflu capsules 75 mg (Genentech, Inc.) | Active comparator | Drug: Tamiflu capsules 75 mgDuring the study session, healthy participants will be administered a single dose of Tamiflu capsules 75 mg of Genentech, Inc. under Fed condition. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects' weight within normal range according to normal values for Body Mass Index (18.50 to 30.00 kg/m2) with minimum of 50 kg weight.
- Subjects with Hemoglobin level ≥ 11.5 G% at the time of screening.
- Subjects with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view).
Key exclusion criteria (21 listed)
- Hypersensitivity to Oseltamivir or related class of drugs or any of its excipients or to heparin.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing of period 01.
- Presence of significant alcoholism or drug abuse.
- History or presence of significant smoking (more than 10 cigarettes or beedis/day).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oseltamivir Phosphate 75 mg capsulesCapsules, 75 mg, single, oral dose | Drug | Oseltamivir Phosphate 75 mg capsules (Yangtze River) |
| Tamiflu capsules 75 mgCapsules, 75 mg, single, oral dose | Drug | Tamiflu capsules 75 mg (Genentech, Inc.) |
Primary outcome
Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax)
Time frame: 48 hours
Maximum measured concentration over the time span specified
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: 48 hours
The area under the concentration versus time curve, from time 0 to the last measurable concentration, where t = time of last measurable concentration, calculated using linear trapezoidal method
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC)
Time frame: 48 hours
The area under the concentration versus time curve from time 0 to infinity AUC0-∞ = AUC0-t + Clast/Kel; where Clast is last measurable concentration, Kel is elimination rate constant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejas Talati, MBBS principal investigator
Veeda Clinical Research Pvt. Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oseltamivir Phosphate 75 mg capsules and Tamiflu capsules 75 mg in people with Bioequivalence, run by Austarpharma, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.