Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State

NCT06768619 | Completed

• 1 other identifier: TQZ3469-BE-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (8)

• Maximum Concentration (Cmax)

  Maximum Concentration

  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.

  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

  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

  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

  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

  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

  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

  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

  From the date of randomization until the date of withdrawal from the clinical trial for any reason, assessed up to 18 days

Study Arms (2)

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.

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.

Drug: Group 2: single-dose of reference formulation+single-dose of test formulation

Interventions

Group 1: single-dose of test formulation+single-dose of reference formulation DRUG

Eltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist.

Group 1: single-dose of test formulation+single-dose of reference formulation

Group 2: single-dose of reference formulation+single-dose of test formulation DRUG

Eltrombopag olamine is a small molecule non peptide thrombopoietin receptor agonist.

Group 2: single-dose of reference formulation+single-dose of test formulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Changchun University of Traditional Chinese Medicine Affiliated Hospital

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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.

  PMID: 41653397 DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 10, 2025
• Study Start: March 20, 2023
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: December 16, 2025

Record last verified: 2025-01

Locations

CN (1)