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A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480049
First Posted: June 24, 2015
Last Update Posted: June 24, 2015
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.
Collaborator:
Sandoz
Information provided by (Responsible Party):
Genuine Research Center, Egypt
  Purpose
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Montelukast fromAsmakast10 mg tablets (Man. by Minapharm Egypt for Novartis Pharma Egypt S.A.E (Sandoz), Egypt) and Singulair10 mg tablets (Produced by Global Napi Pharmaceuticals, Egypt under license from: Merck & Co. Inc., USA) after a single oral dose administration of each to healthy adults under fasting conditions.

Condition Intervention Phase
Healthy Drug: Asmakast Drug: Singulair Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genuine Research Center, Egypt:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 26
Study Start Date: August 2014
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Test
test drug (Asmakast)1 tablet contains 10 mg Montelukast
Drug: Asmakast
1 tablet contains 10 mg of montelukast
Other Name: Singulair
Active Comparator: B Reference
reference drug (Singulair) 1 tablet contains 10 mg Montelukast
Drug: Singulair
1 tablet contains 10 mg of montelukast

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female, age 18 to 55 years, inclusive.
  2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
  3. Medical demographics without evidence of clinically significant deviation from normal medical condition.
  4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
  5. Subject does not have allergy to the drugs under investigation.

Exclusion Criteria:

  1. Subjects with known allergy to the products tested.
  2. Subjects whose values of BMI were outside the accepted normal ranges.
  3. Female subjects who are pregnant, nursing or taking birth control pills.
  4. Medical demographics with evidence of clinically significant deviation from normal medical condition.
  5. Results of laboratory tests which are clinically significant.
  6. Acute infection within one week preceding first study drug administration.
  7. History of drug or alcohol abuse.
  8. Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
  9. Subject is on a special diet (for example subject is vegetarian).
  10. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
  11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
  12. Subject has a history of severe diseases which have direct impact on the study.
  13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
  14. Subject intends to be hospitalized within 6 weeks after first study drug administration.
  15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Egypt
Genuine Research Center GRC
Cairo, Egypt
Sponsors and Collaborators
Genuine Research Center, Egypt
Sandoz
Investigators
Study Director: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center
  More Information

Additional Information:
Responsible Party: Genuine Research Center, Egypt
ClinicalTrials.gov Identifier: NCT02480049     History of Changes
Other Study ID Numbers: GRC/1/14/523
First Submitted: June 14, 2015
First Posted: June 24, 2015
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action