ThrombocytopeniaNCT06768619
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
A study testing Group 1: single-dose of test formulation+single-dose of reference formulation and Group 2: single-dose of reference formulation+single-dose of test formulation in people with Thrombocytopenia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Group 1: single-dose of test formulation+single-dose of reference formulation and Group 2: single-dose of reference formulation+single-dose of test formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to 27 Apr 2023
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Changchun University of Traditional Chinese Medicine Affiliated Hospital
Changchun, Jilin, 130021
About this study
Official title: A Multicenter, Randomized, Open-label, Two-formulation, Two-sequence, Two-period Crossover Study to Evaluate the Bioequivalence of Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions. According to the randomized crossover self-control method, healthy volunteer subjects were orally administered with Eltrombopag Olamine Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Evaluate the human bioequivalence of single dose Reference Listed Drug (RLD) after meals, providing reference for clinical evaluation and medication use.
- Conditions
- Thrombocytopenia
- Being tested
- Group 1: single-dose of test formulation+single-dose of reference formulation, Group 2: single-dose of reference formulation+single-dose of test formulation
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: single-dose of test formulation+single-dose of reference formulationDrug
Eltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist.
Group 2: single-dose of reference formulation+single-dose of test formulationDrug
Eltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: single-dose of test formulation+single-dose of reference formulation | Active comparator | 18 subjects were enrolled, of whom 9 received the trial drug and 9 received reference preparation. Receives: Drug: Group 1: single-dose of test formulation+single-dose of reference formulation |
| Group 2: single-dose of reference formulation+single-dose of test formulation | Active comparator | 18 subjects were enrolled, of whom 9 received the trial drug and 9 received reference preparation. Receives: Drug: Group 2: single-dose of reference formulation+single-dose of test formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax)
Maximum Concentration
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Time to maximum concentration (Tmax)
Time to maximum concentration following drug administration.
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Area under the drug-time curve (AUC)
Area under the drug-time curve
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Apparent terminal elimination half-life (t1/2)
Apparent terminal elimination half-life following drug administration
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Apparent volume of distribution (Vd/F)
Apparent volume of distribution
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Clearance rate (CL/F)
Clearance rate
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Apparent terminal elimination rate constant (λz)
Apparent terminal elimination rate constant
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Relative bioavailability (F)
Relative bioavailability
Measured: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Secondary outcomes (1)
Incidence of adverse events
Occurrence of all adverse events (aes), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.
Measured: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start20 Mar 2023
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768619
- Sponsor's protocol ID
- TQZ3469-BE-01
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu K, Ren Q, Wang Y, Zhou Y, Liu Z, Cheng Y, Deng Q, Cui Y, Yang H. A Single-Center, Randomized, Open-Label, Two-Formulation, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of Two Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State. Clin Drug Investig. 2026 Mar;46(3):321-330. doi: 10.1007/s40261-026-01528-0. Epub 2026 Feb 7.
PubMed 41653397
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Two-formulation, Two-sequence, Two-period Crossover Study to Evaluate the Bioequivalence of Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State
- ClinicalTrials.gov ID
- NCT06768619
- Acronym / sponsor ID
- TQZ3469-BE-01
- Conditions
- Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 10 Jan 2025 (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.
The overall design of this clinical study is a single center, randomized, open label, single dose, two sequence, two cycle bioequivalence trial in healthy individuals under fed conditions. According to the randomized crossover self-control method, healthy volunteer subjects were orally administered with Eltrombopag Olamine Tablets produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Evaluate the human bioequivalence of single dose Reference Listed Drug (RLD) after meals, providing reference for clinical evaluation and medication use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: single-dose of test formulation+single-dose of reference formulation | Active comparator | Drug: Group 1: single-dose of test formulation+single-dose of reference formulation18 subjects were enrolled, of whom 9 received the trial drug and 9 received reference preparation. |
| Group 2: single-dose of reference formulation+single-dose of test formulation | Active comparator | Drug: Group 2: single-dose of reference formulation+single-dose of test formulation18 subjects were enrolled, of whom 9 received the trial drug and 9 received reference preparation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
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 |
|---|---|---|
| Group 1: single-dose of test formulation+single-dose of reference formulationEltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist. | Drug | Group 1: single-dose of test formulation+single-dose of reference formulation |
| Group 2: single-dose of reference formulation+single-dose of test formulationEltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist. | Drug | Group 2: single-dose of reference formulation+single-dose of test formulation |
Primary outcome
Maximum Concentration (Cmax)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Maximum Concentration
Time to maximum concentration (Tmax)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Time to maximum concentration following drug administration.
Area under the drug-time curve (AUC)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Area under the drug-time curve
Apparent terminal elimination half-life (t1/2)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Apparent terminal elimination half-life following drug administration
Apparent volume of distribution (Vd/F)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Apparent volume of distribution
Clearance rate (CL/F)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Clearance rate
Apparent terminal elimination rate constant (λz)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Apparent terminal elimination rate constant
Relative bioavailability (F)
Time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration
Relative bioavailability
1 secondary outcome
Incidence of adverse events
Time frame: From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 18 days
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 16 Dec 2025.
- Derived from this study: PubMed 41653397Wu K, Ren Q, Wang Y, Zhou Y, Liu Z, Cheng Y, Deng Q, Cui Y, Yang H. A Single-Center, Randomized, Open-Label, Two-Formulation, Two-Sequence, Two-Period Crossover Study to Evaluate the Bioequivalence of Two Eltrombopag Olamine Tablets (25 mg) in Healthy Chinese Subjects in the Fed State. Clin Drug Investig. 2026 Mar;46(3):321-330. doi: 10.1007/s40261-026-01528-0. Epub 2026 Feb 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: single-dose of test formulation+single-dose of reference formulation and Group 2: single-dose of reference formulation+single-dose of test formulation in people with Thrombocytopenia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
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 4 inclusion and 20 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 16 Dec 2025. 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 China. 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.
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 Concentration (Cmax) (time frame: Before administration and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12, 24, 48, 72hours after administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768619, which also lists 1 linked publication.
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 16 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.