Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT03561558
Brief Summary:
To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety
Detailed Description:
Total 30 normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test (5 ml of oral suspension containing 200 mg of ibuprofen) or the Reference Product (10ml of oral suspension containing 200 mg of ibuprofen) with 200 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to administration of the study drugs and for four (4) hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour to administration of the study drugs and 2 hours after administration of the study drugs in each period. A total of 20 blood samples will be withdrawn for pharmacokinetic profiling during each study period. The plasma concentrations of R- and S-enantiomers of ibuprofen will be measured by a validated LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval of S-enantiomers of ibuprofen, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-t.
Study:
NCT03561558
Study Brief:
Protocol Section:
NCT03561558