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First received: November 14, 2024

Clinical Trial: A Study to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules in Healthy Subjects

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Pharmacokinetics

Study Type: INTERVENTIONAL


Official Title: A Single-Center, Open-label, Randomized, Single Dose, Two-way Crossover Design to Evaluate the Relative Bioavailability of Two Different Pimicotinib Capsules Under Fasting Conditions in Healthy Subjec

Brief Summary: This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition.26 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B .Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.

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