Shandong Province Qianfoshan Hospital
Jinan, Shandong, 250000, China
NCT Number: NCT06976346
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.
Time frame: From 0 hour predose up to 12 hours postdose
Time frame: From 0 hour predose up to 12 hours postdose
Time frame: From 0 hour predose up to 12 hours postdose
Time frame: From 0 hour predose up to 12 hours postdose
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 22)
Jiangsu HengRui Medicine Co., Ltd.
Industry
Pharmacokinetics and Relative Bioavailability Study of HRG2010 Capsule After Single Dose Administration
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