A Randomized, Open-Label, Crossover Study to Demonstrate Bioequivalence Between Lorcaserin Extended Release (XR) Tablets Manufactured in Kawashima and Lorcaserin XR Tablets Manufactured in Zofingen Under Fasted Conditions in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Lorcaserin
研究概览
简要总结
The purpose of this study is to demonstrate the bioequivalence between lorcaserin XR tablets manufactured in Kawashima and lorcaserin XR tablets manufactured in Zofingen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B)
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.
干预措施: Lorcaserin manufactured at Zofingen (Drug)
Lorcaserin 20 mg manufactured at: Zofingen (A) + Kawashima (B)
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.
干预措施: Lorcaserin manufactured at Kawashima (Drug)
Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A)
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.
干预措施: Lorcaserin manufactured at Zofingen (Drug)
Lorcaserin 20 mg manufactured at: Kawashima (B) + Zofingen (A)
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.
干预措施: Lorcaserin manufactured at Kawashima (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Lorcaserin
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)
- 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)