Generic platelet drug put to the test: will it match the original?
NCT ID NCT06768619
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study checked whether a generic eltrombopag olamine tablet works the same as the brand-name version in 36 healthy Chinese adults after a meal. Participants took a single dose of each formulation in random order, and researchers measured how the drug moved through their bodies. The goal was to confirm bioequivalence, which could lead to a more affordable option for treating low platelet counts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eltrombopag olamine (a drug that boosts platelet production)
- What this could lead to
- If successful, this could confirm that the generic tablet is equivalent to the brand-name drug, offering a more affordable treatment option for people with low platelet counts.
- What could go wrong
- This is a small, early-stage bioequivalence study in healthy people, not patients. It does not test whether the drug actually improves health outcomes, and results may not predict real-world effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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36 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Apr 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy subjects aged 18 to 65 years, inclusive of both 18 and 65 years old; * Male subjects with a weight of not less than 50.0 kilograms, and female subjects with a weight of not less than 45.0 kilograms; Body Mass Index (BMI) = weight (kg) / height2 (m2), with a BMI range of 18 to 28 kg/m2, inclusive of the boundary values; * Subjects willing to abstain from childbearing from 2 weeks prior to screening until 6 months after the last administration of the study medication, and voluntarily adopt effective contraceptive measures, with no plans for sperm or egg donation, and ensure the use of one or more non-pharmaceutical contraceptive methods during sexual activity from 2 weeks prior to screening until 6 months after the last administration of the study medication; * Subjects must sign an informed consent form before the trial, fully understand the content, process, and potential adverse reactions of the trial, and be able to complete the study according to the requirements of the trial protocol. Exclusion Criteria: * Subjects with any clinically significant abnormal clinical manifestations that have occurred or are ongoing and require exclusion, including but not limited to neurological/psychiatric, respiratory, cardiovascular, gastrointestinal (any history of gastrointestinal diseases affecting drug absorption), hematopoietic and lymphatic systems, hepatorenal function, endocrine system, and immune system diseases; * Subjects with any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers, or with any coagulation disorders (such as von Willebrand's disease or hemophilia) or a history of bleeding disorders; * Subjects with clinically significant abnormalities in physical examination, vital sign measurements, electrocardiogram, and laboratory tests; * Subjects with clinically significant abnormalities in prothrombin time (PT) and activated partial thromboplastin time (APTT) tests; * Subjects with abnormal and clinically significant tests for hepatitis B surface antigen, antibodies to hepatitis C virus, antibodies to human immunodeficiency virus, or antibodies to Treponema pallidum; * Subjects with a history of allergy to eltrombopag or its excipients; * Subjects who have donated blood or experienced significant blood loss (≥400mL) within three months prior to the trial; * Subjects with difficulty swallowing tablets; * Subjects with a history of fainting at the sight of needles or blood, or who cannot tolerate venipuncture; * Subjects who have taken any medication that alters liver enzyme activity or combined with inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or quinupristin/dalfopristin, within 28 days before the first intake of the study medication; * Subjects who have taken any prescription or over-the-counter drugs, any vitamin products, or herbal remedies within 28 days before the first intake of the study medication; * Subjects who have taken the investigational drug or participated in other drug clinical trials and received corresponding study medications within the last three months; * Subjects with a history of drug abuse within the last six months, or who have used drugs within the last three months, or who test positive for drug abuse screening; * Subjects with a history of alcohol abuse within the last six months, defined as a weekly alcohol intake exceeding 14 units (1 unit = 360 mL of beer with 5% alcohol content or 45 mL of spirits with 40% alcohol content or 150 mL of wine with 12% alcohol content), or who cannot abstain from alcohol during the trial period; * Subjects who smoke more than 5 cigarettes per day within the last six months, or who cannot cease using any tobacco products during the trial period; * Subjects who have consumed any food or drink rich in flavonoids or furanocoumarins, such as grapefruit, pomelo, mango, dragon fruit, grape juice, or orange juice, within 48 hours before administration; * Subjects who have consumed any food or drink containing caffeine, tea, or xanthine within 48 hours before administration; * Subjects who have special dietary requirements during the trial period and cannot comply with the provided diet and corresponding regulations; * Subjects who engage in intense exercise or have significant changes in exercise habits during the trial period; * Subjects whom the investigator deems unsuitable for enrollment for other reasons.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Changchun University of Traditional Chinese Medicine Affiliated Hospital
Changchun, Jilin, 130021, China
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