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The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B) | Experimental | Participants will receive a single oral dose of lorcaserin 20 milligram (mg) XR tablets manufactured at Zofingen (A) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Kawashima (B) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods. |
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| Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A) | Experimental | Participants will receive a single oral dose of lorcaserin 20 mg XR tablets manufactured at Kawashima (B) after a 10-hour overnight fast on Day 1 of treatment period 1 followed by a single oral dose of lorcaserin 20 mg XR tablet manufactured at Zofingen (A) after a 10-hour overnight fast on Day 7 of treatment period 2. A washout period of 5 days will be maintained between the 2 treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin manufactured at Zofingen | Drug | Lorcaserin XR tablets manufactured at Zofingen. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| Number of Participants With Markedly Abnormal Laboratory Values | Baseline up to Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
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| Lorcaserin manufactured at Kawashima | Drug | Lorcaserin XR tablets manufactured at Kawashima. |
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| 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 |
| ID | Term |
|---|---|
| C506658 | lorcaserin |
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