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Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State

NCT06768632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-01-10

No results posted yet for this study

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

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-02
Primary Completion
2020-04-27
Completion
2023-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06768632 on ClinicalTrials.gov