Healthy Participants
Conditions
Keywords
Lorcaserin, Bioequivalence, Extended release, Tablets, Phase 1, Healthy
Brief summary
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
Interventions
DRUGLorcaserin manufactured at Zofingen
Lorcaserin XR tablets manufactured at Zofingen.
DRUGLorcaserin manufactured at Kawashima
Lorcaserin XR tablets manufactured at Kawashima.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-smoking, healthy participants at the time of informed consent. * Body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m\^2) (inclusive) at Screening.
Exclusion criteria
* Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing. * Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing; eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism. * History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug, cotinine, or alcohol test at Screening or Baseline. * Participants who contravene the restrictions on concomitant medications, food and beverages. * Currently enrolled in another clinical study or used any investigational drug or device within 4 weeks preceding informed consent. * Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal elimination phase half-life (t½) of Lorcaserin | predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days |
| Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC [0-t]) of Lorcaserin | predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days |
| Area under the concentration-time curve from zero time extrapolated to infinite time (AUC [0-inf]) of Lorcaserin | predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days |
| Area under the concentration-time curve from zero time to 72 hour (AUC [0-72h]) of Lorcaserin | predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, and 72 hours postdose in each treatment period; treatment period length = 4 days |
| Time to Maximum Observed Plasma Concentration (tmax) of Lorcaserin | predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days |
| Maximum Observed Plasma Concentration (Cmax) of Lorcaserin | predose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 24, 36, 48, 72, and 96 hours postdose in each treatment period; treatment period length = 4 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Markedly Abnormal Laboratory Values | Baseline up to Day 11 |
| Number of Participants With Change From Baseline in Vital Signs Parameters | Baseline, Day 1, Day 2, Day 6, Day 7, Day 8, and Day 11 |
| Number of Participants With Clinically Significant Findings in Physical examinations | Baseline and Day 11 |
| Number of Participants With One or More Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | Baseline up to 28 days after last dose of study drug (Day 35) |
Countries
United States
Outcome results
None listed