Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting 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 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.

Study Overview

• Status: Completed
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: Group 1: single-dose of test formulation+single-dose of reference formulation; Drug: Group 2: single-dose of reference formulation+single-dose of test formulation

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Lianyungang, Jiangsu, China, 222000
      • Lianyungang First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: single-dose of test formulation+single-dose of reference formulation; 18 subjects were enrolled, of whom 9received the Investigational drug and 9 received reference preparation.	Drug: Group 1: single-dose of test formulation+single-dose of reference formulation; Eltrombopag Tablets is a small molecule non peptide thrombopoietin receptor agonist.
Active Comparator: Group 2: single-dose of reference formulation+single-dose of test formulation; 18 subjects were enrolled, of whom 9received the Investigational drug and 9 received reference preparation.	Drug: Group 2: single-dose of reference formulation+single-dose of test formulation; Eltrombopag Tablets is a small molecule non peptide thrombopoietin receptor agonist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours 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, 72 hours after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.	From the first dose to the end of follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cytopenia; Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: ZDTQ-BE-2019-AQBP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No