This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will stay at site till Day 2 after PK collection. All subjects will return to the clinical sites at designated study days for dosing, PK sample collections and assigned clinical activities. All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the gluteal muscle with the last dose on Day 148. End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last dosing. At EOS visit, subjects will complete the study after a series of assigned clinical assessments. A 30-day follow up call will be conducted by the clinical research staff to ensure participant's well-being.
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will stay at site till Day 2 after PK collection. All subjects will return to the clinical sites at designated study days for dosing, PK sample collections and assigned clinical activities. All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the gluteal muscle with the last dose on Day 148. On the day before the last dosing day visit (Day 140 for LY03010 treatment group and Day 147 for SUSTENNA treatment group), subjects will come to the clinical facility and stay at sites for 8 days for PK collection and other assigned activities. The schedules of assessments for each treatment group are listed in Table 2 and Table 3. End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last dosing. At EOS visit, subjects will complete the study after a series of assigned clinical assessments. A 30-day follow up call will be conducted by the clinical research staff to ensure participant's well-being.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
281
LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.
INVEGA SUSTENNA (234 mg, 156 mg) is manufactured by Janssen Pharmaceuticals, Inc and is commercially available.
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
CNS Network, LLC
Torrance, California, United States
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Hassman Research Institute
Berlin, New Jersey, United States
Hassman Research Institute
Marlton, New Jersey, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
The relative bioavailability of LY03010 versus INVEGA SUSTENNA at steady-state
The relative bioavailability of LY03010 versus INVEGA SUSTENNA will be evaluated by the analysis of the area under the plasma concentration-time curve over a dosing interval at steady state (AUCtau-ss) of plasma paliperidone.
Time frame: 176 days
Relative Bioavailability of LY03010 compared to Listed Drug
The relative bioavailability of LY03010 versus INVEGA SUSTENNA will be evaluated by the analysis of maximum peak steady-state (Cmax-ss) of plasma paliperidone concentration during a dosage interval.
Time frame: 176 days
Compare the PK profile between LY03010 and INVEGA SUSTENNA at the initial phase
AUC of paliperidone from the two different initial dosing regimens will be compared.
Time frame: 36 days
Compare the PK profile between the two treatments at the initial phase.
Cmax of paliperidone from the two different initial dosing regimens will be compared.
Time frame: 36 days
Compare the PK profile between the two treatments.
Cmin of paliperidone from the two different initial dosing regimens will be compared.
Time frame: 36 days
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