Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State

NCT06768632 | Completed

• 1 other identifier: ZDTQ-BE-2019-AQBP
• 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 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

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, 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 Outcomes (1)

• Incidence of adverse events

  From the first dose to the end of follow-up

Study Arms (2)

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.

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.

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 Tablets 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 Tablets 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:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

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

Study Sites (1)

Lianyungang First People's Hospital

Lianyungang, Jiangsu, 222000, China

Location

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: January 2, 2020
• Primary Completion: April 27, 2020
• Study Completion: December 30, 2023
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

CN (1)