Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions
- Conditions
- Bioequivalence
- Interventions
- Drug: Maldox tabletsDrug: G-COSPE® tablets
- Registration Number
- NCT04577469
- Lead Sponsor
- Emzor Pharmaceutical Industries Limited
- Brief Summary
To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 500 mg sulfadoxine / 25 mg pyrimethamine tablet Maldox tablets 500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once. 500 mg sulfadoxine / 25 mg pyrimethamine tablet G-COSPE® tablets 500 mg sulfadoxine / 25 mg pyrimethamine tablet will be administered once. G-COSPE® tablets Maldox tablets G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once. G-COSPE® tablets G-COSPE® tablets G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) will be administered once.
- Primary Outcome Measures
Name Time Method Bioequivalence based on Peak Plasma Concentration (Cmax) for Sulfadoxine and Pyrimethamine. 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. 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
- Secondary Outcome Measures
Name Time Method Obtaining the Tmax (Time to reach maximum concentration) for Sulfadoxine and Pyrimethamine 12 weeks The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax.
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 Clinically significant abnormal deviations in ECG QTc interval
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. Clinically significant abnormal deviations. Normal range of blood pressure \> 90/60 and \<140/90 mmHg. Treatment will be offered to those subjects whom blood pressure drops to 90/60 mm Hg or less and the subject will be excluded in case of not responding to treatment.
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. Clinically significant abnormal deviations. Normal range of Pulse 60-100 Bpm.
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. Clinically significant abnormal deviations. The temperature will be measured axillary, orally or using infrared thermometer, standardized across all subjects. Normal range of temperature 36.5-37.5 ºC.
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. Clinically significant abnormal deviations. Normal range of respiratory rate 12-18 B/M
Hematology (Safety and Tolerability) At the end of the study (at 72.00 hours post dosing) Hematology test will include Complete blood count
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 Safety and tolerability: number of subjects with adverse events