ThrombocytopeniaNCT06768632
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting 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 fasting 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2020to 30 Dec 2023
- Phase
- Interventional
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
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Able to complete the study according to the requirements of the trial protocol;
- The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix;
- Male and female subjects aged 18-55 years old (including 18 and 55 years old);
- he body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value);
- Health condition: History of no heart, liver, kidney, digestive tract, nervous system, mental disorders, metabolic disorders, etc；
- The physical examination was normal or abnormal without clinical significance.
Who cannot join
- Smoking more than 5 cigarettes per day in the 3 months before the study;
- Allergic constitution (multi-drug and food allergy);
- A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine);
- Donation or massive blood loss (> 400 mL) within 3 months before screening;
- Taking any drugs that alter liver enzyme activity 28 days before screening;
- Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening;
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- Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion;
- Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone;
- A recent major change in diet or exercise habits;
- Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug;
- A history of dysphagia or any gastrointestinal disorder affecting drug absorption or a history of cholecystectomy or biliary tract disease;
- Have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
- ECG abnormalities have clinical significance;
- The female subjects were lactating or seropositive for pregnancy during the screening or test period;
- Clinically significant abnormalities on clinical examination or other clinical findings (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases);
- Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody positive;
- From the screening stage to the onset of acute illness before study medication;
- Consumption of chocolate, any caffeinated or xanthine-rich food or beverage 48 hours before taking the study drug;
- Have taken any alcohol-based product within 24 hours before taking the study medication;
- Individuals who test positive for alcohol and drugs or have a history of drug abuse within the past five years or have used drugs in the three months prior to the experiment;
- Difficulty in blood collection or inability to tolerate venipuncture blood collection;
- The subject is unable or unable to comply with ward management regulations;
- The subject is unable to complete the experiment due to personal reasons;
- Other researchers determine that it is not suitable for selection in this project.
Trial locations and contacts
1 site in 1 country.
About this study
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 fasting 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. and Reference Listed Drug (RLD) on an empty stomach to evaluate the human bioequivalence of single dose administration, providing reference for their clinical evaluation and medication.
- 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 Tablets is a small molecule non peptide thrombopoietin receptor agonist.
Group 2: single-dose of reference formulation+single-dose of test formulationDrug
Eltrombopag Tablets 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 9received the Investigational 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 9received the Investigational 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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 first dose to the end of follow-up
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 start2 Jan 2020
- Primary completion27 Apr 2020
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- NCT06768632
- Sponsor's protocol ID
- ZDTQ-BE-2019-AQBP
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No