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| Name | Class |
|---|---|
| ClinPharmInvest, LLC | OTHER |
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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
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 A total of 20 blood samples will be withdrawn for pharmacokinetic profiling during each study period.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen D, oral suspension | Experimental | Ibuprofen oral suspension, 200 mg/ 5 ml is the test product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (5 ml containing 200 mg of ibuprofen) of suspension. |
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| Nurofen® for Children, oral suspension | Active Comparator | Nurofen® for Children oral suspension, 100 mg/ 5 ml is the reference product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (10 ml containing 200 mg of ibuprofen) of suspension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen D | Drug | Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary pharmacokinetic parameter for S-enantiomer of ibuprofen | Peak Plasma Concentration (Cmax) | 8 days |
| Primary pharmacokinetic parameter for S-enantiomer of ibuprofen | Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the investigational products (testing and reference) | Number of adverse events, number of deaths, number of severe adverse events in subjects who have taken at least one dose of investigational products. | 22 days |
| Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Khokhlov, Professor | ClinPharmInvest, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2" | Yaroslavl | Yaroslavl Oblast | 150010 | Russia |
The Company may provide the individual participant data after privacy protection on case by case basis.
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This study is an open label study; the subjects and the investigator will not be blinded towards the identity of the investigational products. However, analysts will be blinded towards identity of investigational products administered.
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| Nurofen® for Children | Drug | Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK |
|
Area under the plasma concentration versus time curve from time 0 to to infinite time(AUC0-∞) |
| 8 days |
| Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen | Time of maximum measured plasma concentration (Tmax) | 8 days |
| Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen | Elimination or terminal half-life (T1/2) | 8 days |
| Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen | Elimination rate constant (Kel) | 8 days |
| Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen | Residual area (AUCresid) | 8 days |