drugset / Trial / NCT06976346

Relative Bioavailability Study of HRG2010 in Healthy Subjects

NCT06976346

Phase 1 Completed 16 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedCrossoverOpen-labelDiagnostic

Summary

This is a single-center, randomized, open-label, four-period, crossover study. Primary Objective: 1. To evaluate the pharmacokinetic characteristics of healthy subjects after a single oral dose of HRG2010 capsules at dose 1 and dose 2 under fasting conditions, and to compare these with the pharmacokinetic characteristics of Carbidopa/Levodopa Extended-Release Tablets (Sinemet®) and Benserazide/Levodopa Tablets (Madopar®). Secondary Objective 2. To assess safety following administration.

Timeline

Start
2021-09-10
Primary completion
2021-10-07
Completion
2021-10-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Benserazide/Levodopa Unknown Oral
Subject Carbidopa/Levodopa Unknown Oral
Subject HRG2010 Unknown Oral

Indications