- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536415
Bioequivalence Study of Oseltamivir Phosphate and TAMIFLU Under Fed Condition in Healthy Volunteers
August 28, 2020 updated by: Austarpharma, LLC
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Edison, New Jersey, United States, 08837
- Recruiting
- Austarpharma Llc
-
Contact:
- Doris Zhang
- Phone Number: 732-331-7315
- Email: doris.zhang@austarpharma.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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).
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oseltamivir Phosphate 75 mg capsules (Yangtze River)
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.
|
Capsules, 75 mg, single, oral dose
|
Active Comparator: Tamiflu capsules 75 mg (Genentech, Inc.)
During the study session, healthy participants will be administered a single dose of Tamiflu capsules 75 mg of Genentech, Inc. under Fed condition.
|
Capsules, 75 mg, single, oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax)
Time Frame: 48 hours
|
Maximum measured concentration over the time span specified
|
48 hours
|
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
|
48 hours
|
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.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tejas Talati, MBBS, Veeda Clinical Research Pvt. Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2020
Primary Completion (Actual)
August 27, 2020
Study Completion (Anticipated)
August 27, 2020
Study Registration Dates
First Submitted
August 28, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 2, 2020
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
August 28, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-VIN-0051
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bioequivalence
-
Pharmtechnology LLCRecruitingBioequivalenceRussian Federation
-
Emzor Pharmaceutical Industries LimitedNot yet recruiting
-
Pharmtechnology LLCClinPharmInvest, LLCNot yet recruitingBioequivalenceRussian Federation
-
Indiana UniversityFood and Drug Administration (FDA)Completed
-
AstraZenecaCompletedBioequivalenceUnited States
-
Future University in EgyptCompleted
-
Cross Research S.A.Zambon SpACompleted
-
Laboratorios Andromaco S.A.Completed
-
Emzor Pharmaceutical Industries LimitedUnknown
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
Clinical Trials on Oseltamivir Phosphate 75 mg capsules
-
Dalian Zhen-Ao Bio-Tech Co., Ltd.Unknown
-
Pharmahungary GroupHoffmann-La RocheCompleted
-
University of ManitobaHoffmann-La RocheWithdrawnInfluenza A Virus Infection | Influenza B Virus InfectionCanada
-
Tongji HospitalRecruitingST Elevation Myocardial Infarction | STEMIChina
-
Janssen Research & Development, LLCJanssen PharmaceuticalsCompletedInfluenza AUnited States, Germany, Bulgaria, Canada, Estonia, Latvia, Belgium, Puerto Rico
-
Seoul National University HospitalCompletedHealthyKorea, Republic of
-
Laboratorios Andromaco S.A.CompletedBioequivalenceIndia
-
GlaxoSmithKlineTerminatedVirus DiseasesUnited States, Sweden, Russian Federation, Romania
-
Massachusetts General HospitalCompletedAttention Deficit Hyperactivity DisorderUnited States
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Qingdao Municipal Hospital; Beijing Luhe Hospital; Cangzhou People's Hospital; First... and other collaboratorsUnknown