Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
Interventions
DRUGPlacebo
DRUGASC-01
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers aged 20 to 40 years. * Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.
Exclusion criteria
* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study. * History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of Sertraline | predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline | predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A: ASC-01 Placebo First Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.
Period II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting. | 25 |
| Arm B: Sertraline First Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.
Period II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period I | Physician Decision | 1 | 4 |
| Wash-out Period (at Least 10 Days) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Arm B: Sertraline First | Total | Arm A: ASC-01 Placebo First |
|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 4.3 | 26.8 years STANDARD_DEVIATION 4.3 | 25.2 years STANDARD_DEVIATION 3.7 |
| Race/Ethnicity, Customized Japanese | 25 Participants | 50 Participants | 25 Participants |
| Region of Enrollment Japan | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 50 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 48 |
| other Total, other adverse events | 9 / 46 | 19 / 48 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 |
Outcome results
Primary
Peak Plasma Concentration (Cmax) of Sertraline
Time frame: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
Population: Bioequivalence Analysis Set comprised all subjects for whom the Cmax and AUCt were determined in both Period I and Period II.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASC-01 Placebo | Peak Plasma Concentration (Cmax) of Sertraline | 28.3 ng/mL | Standard Deviation 8.31 |
| Sertraline | Peak Plasma Concentration (Cmax) of Sertraline | 28.8 ng/mL | Standard Deviation 10.1 |
Secondary
Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline
Time frame: predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose
Population: Bioequivalence Analysis Set comprised all subjects for whom the Cmax and AUCt were determined in both Period I and Period II.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASC-01 Placebo | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline | 835 ng*h/mL | Standard Deviation 363 |
| Sertraline | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline | 856 ng*h/mL | Standard Deviation 421 |