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Bioequivalence of Eltrombopag 75 mg Film-Coated Tablets in Healthy Subjects Under Fasting Conditions
EU CTIS ID: 2022-502701-15-00
What this study is testing
To demonstrate bioequivalence between Test and Reference products under fasting conditions.
- Human Pharmacology (Phase I)- Bioequivalence Study
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets the following criteria: a) Is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to the first dose administration at least 1 week after the last dose administration.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.
- Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive.
You likely can't join if
- Eastern-/Southeastern-Asian (i.e., Chinese, Japanese, Taiwanese or Korean) subjects.
- History of cataracts.
- Platelets levels below the lower limit of the normal range or above 400 x 109/L.
- Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) outside the normal range.
- Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
- Total bilirubin above the ULN.
See the full eligibility criteria
Who can join
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets the following criteria: a) Is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to the first dose administration at least 1 week after the last dose administration.
- Negative SARS-CoV-2 test or valid EU Digital COVID-19 Recovery Certificate.
- Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis C virus antibodies (anti-HCVAb).
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
What rules you out
- Eastern-/Southeastern-Asian (i.e., Chinese, Japanese, Taiwanese or Korean) subjects.
- History of cataracts.
- Platelets levels below the lower limit of the normal range or above 400 x 109/L.
- Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) outside the normal range.
- Estimated renal creatinine clearance (CrCL) below 90 mL/min, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average surface area of 1.73 m2.
- Total bilirubin above the ULN.
- Resting heart rate <50 bpm in ECG.
- Baseline QTcF interval >450 msec if man or >470 msec if woman.
- Positive result in drugs-of-abuse, ethanol or cotinine tests.
- Use of a depot injection or an implant of any drug within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
- Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- If woman, positive pregnancy test in serum.
- If woman, she is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Known severe hypersensitivity reaction to any other drug.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of prescription or nonprescription medicinal products (such as vitamins, food supplements, mineral and herbal supplements, including St John’s Wort), within the previous 2 weeks, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week.
- Positive result in drugs-of-abuse, ethanol, or cotinine tests.
- If woman, positive pregnancy test in urine.
- Any other condition that the investigator considers to render the subject unsuitable for the study period.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject’s safety.
- History of splenectomy.
- History of liver impairment.
- History of thromboembolic event.
- History of risk factors for thromboembolic events (e.g., inherited hypercoagulable disorders and auto-immune disorders with hypercoagulable states).
- History of platelets disorders.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.