Randomized,One-period,Single Oral Dose,Open-label,Parallel,Bioequivalence Study to Compare 500mg Sulfadoxine/25mg Pyrimethamine Tablet Versus G-COSPE® Tablet (500mg Sulfadoxine/25mg Pyrimethamine) in Healthy Subjects Under Fasting Condition
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 52
- 主要终点
- Bioequivalence based on Peak Plasma Concentration (Cmax) for Sulfadoxine and Pyrimethamine.
研究概览
简要总结
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.
详细描述
The aim of this study is to assess bioequivalence between a single dose from the test product, Sulfadoxine/ Pyrimethamine tablets (500 mg sulfadoxine / 25 mg pyrimethamine), manufactured by Ms. Emzor Pharmaceuticals Industries Ltd, Nigeria versus the reference product G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) manufactured by Guilin Pharmaceutical Co. Ltd, China under fasting conditions and to monitor the safety of the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
500 mg sulfadoxine / 25 mg pyrimethamine tablet
500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once.
干预措施: Maldox tablets (Drug)
500 mg sulfadoxine / 25 mg pyrimethamine tablet
500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once.
干预措施: G-COSPE® tablets (Drug)
G-COSPE® tablets
G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once.
干预措施: Maldox tablets (Drug)
G-COSPE® tablets
G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once.
干预措施: G-COSPE® tablets (Drug)
结局指标
主要结局
Bioequivalence based on Peak Plasma Concentration (Cmax) for Sulfadoxine and Pyrimethamine.
时间窗: 12 weeks
The average bioequivalence of the products will be concluded if the two-sided 90 % confidence interval for the test to reference ratio of the population means is within 80.00 - 125.00 % for the ln transformed data Cmax of sulfadoxine \& pyrimethamine
Area under the plasma concentration versus time curves (AUC0 - 72) for Sulfadoxine and Pyrimethamine.
时间窗: 12 weeks
The average bioequivalence of the products will be concluded if the two-sided 90 % confidence interval for the test to reference ratio of the population means is within 80.00 - 125.00 % for the ln transformed data AUC0 -72 of sulfadoxine \& pyrimethamine
次要结局
- Obtaining the Tmax (Time to reach maximum concentration) for Sulfadoxine and Pyrimethamine(12 weeks)
- ECG QTc Interval (safety and tolerability)(ECG recording will be performed 4 hours post- dosing and at the end of the study (at 72.00 hours post dosing) as follow-up tests)
- Blood pressure (safety and tolerability)(At 1-hour pre-dosing; 2, 4, 6, 8, 12 and 23 hours post-dosing (±45 minutes of scheduled time). Blood pressure will also be measured at 48 and 72 hours post-dosing upon ambulatory sample collection.)
- Pulse (safety and tolerability)(At 1-hour pre-dosing; 2, 4, 6, 8, 12 and 23 hours post-dosing (±45 minutes of scheduled time). Pulse will also be measured at 48 and 72 hours post-dosing upon ambulatory sample collection.)
- Temperature (safety and tolerability)(At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours post-dosing (±45 minutes of scheduled time). Temperature will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.)
- Respiratory rate (safety and tolerability)(At 1-hour pre-dosing; 2, 6, 10, 14, 18, 22 & 23 hours post-dosing (±45 minutes of scheduled time). Respiratory rate will also be measured at 48 and 72 hours post-dosing upon ambulatory sample.)
- Hematology (Safety and Tolerability)(At the end of the study (at 72.00 hours post dosing))
- Number of Subjects With AEs(At 12 and 1-hour pre-dosing; 2, 4, 6, 8, 10, 12, 23, 48 and 72 hours post-dosing)