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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
In each period under fasting conditions, subjects received oral administration of either HRG2010 Capsule dose 1, HRG2010 Capsule dose 2, Sinemet®, or Madopar®.
Shandong Province Qianfoshan Hospital
Jinan, Shandong, China
Cmax: Maximum plasma concentration. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Time frame: From 0 hour predose up to 12 hours postdose
Incidence of treatment emergent AEs (TEAEs)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 22)
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