Status and phase
Conditions
Treatments
About
To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by simvastation acid) in healthy subjects.
To assess the safety of single doses of simvastation administered with and without PEX168
Full description
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of simvastatin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 10 weeks, which included up to a 14-day Screening Period, a 34-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in Shanghai Mental Health Center (SMHC)of China Treatment.All subjects receives a single 40-mg oral dose of simvastatin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a second single 40-mg oral dose of simvastatin on Day 33.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
An individual who met all of the following criteria was eligible for the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
16 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal