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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Eltrombopag Tablets is a small molecule non peptide thrombopoietin receptor agonist.
Eltrombopag Tablets is a small molecule non peptide thrombopoietin receptor agonist.
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China
Maximum Concentration (Cmax)
Maximum Concentration
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Incidence of adverse events
Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded.
Time frame: From the first dose to the end of follow-up
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