A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02480049|
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Asmakast Drug: Singulair||Phase 1|
19 blood samples will be drawn in each period. The total volume of blood will not exceed 200 ml throughout the whole study.0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00,2.50, 3.00,3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, and 24.00 hours post dose. Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair® 10mg Tabs (Merck & Co, Egypt) to Healthy Adult Volunteers|
|Study Start Date :||August 2014|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
Experimental: A Test
test drug (Asmakast)1 tablet contains 10 mg Montelukast
1 tablet contains 10 mg of montelukast
Other Name: Singulair
Active Comparator: B Reference
reference drug (Singulair) 1 tablet contains 10 mg Montelukast
1 tablet contains 10 mg of montelukast
- Maximal measured plasma concentration (Cmax) [ Time Frame: 24 hours ]Serial blood samples for determination of study drug will be collected pre-dose and at 0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00,2.50, 3.00,3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, and 24.00 hours postdose
- measurable concentration (t) (AUC [0 to t]) [ Time Frame: 24 hours ](AUC [0 to t]) will be calculated by the linear trapezoidal method.
- Area Under the plasma concentration-time curve from time zero to infinity (AUC [0 to infinity]) [ Time Frame: 24 hours ]AUC (0 to infinity) will be calculated as the sum of the AUC (0 to t) plus the ratio of the last measurable plasma concentration to the elimination rate constant
- Time of the maximum plasma concentration (tmax)measurable concentration (t) (AUC [0 to t]) [ Time Frame: 24 hours ]If the Tmax occurs at more than time point, then tmax will be considered for the first occurrence..
- Apparent first-order elimination or terminal rate constant (K¬e) [ Time Frame: 24 hours ]K¬e will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations
- Terminal half life (t1/2e) [ Time Frame: 24 hours ]The elimination or terminal half-life will be calculated as 0.693/ Ke
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480049
|Genuine Research Center GRC|
|Study Director:||Ahmed Elshafeey, Ph.D. Pharma||Genuine Research Center|