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

NCT02480049 | Completed Phase 1

• 1 other identifier: GRC/1/14/523
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximal measured plasma concentration (Cmax)

  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

  24 hours

• measurable concentration (t) (AUC [0 to t])

  (AUC \[0 to t\]) will be calculated by the linear trapezoidal method.

  24 hours

• Area Under the plasma concentration-time curve from time zero to infinity (AUC [0 to infinity])

  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

  24 hours

Secondary Outcomes (3)

• Time of the maximum plasma concentration (tmax)measurable concentration (t) (AUC [0 to t])

  24 hours

• Apparent first-order elimination or terminal rate constant (K¬e)

  24 hours

• Terminal half life (t1/2e)

  24 hours

Study Arms (2)

A Test

EXPERIMENTAL

test drug (Asmakast)1 tablet contains 10 mg Montelukast

Drug: Asmakast

B Reference

ACTIVE COMPARATOR

reference drug (Singulair) 1 tablet contains 10 mg Montelukast

Drug: Singulair

Interventions

Asmakast DRUG

1 tablet contains 10 mg of montelukast

Also known as: Singulair

A Test

Singulair DRUG

1 tablet contains 10 mg of montelukast

B Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Subjects with known allergy to the products tested.
• Subjects whose values of BMI were outside the accepted normal ranges.
• Female subjects who are pregnant, nursing or taking birth control pills.
• Medical demographics with evidence of clinically significant deviation from normal medical condition.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• 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.
• Subject is on a special diet (for example subject is vegetarian).
• 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.
• 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.
• Subject has a history of severe diseases which have direct impact on the study.
• Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
• Subject intends to be hospitalized within 6 weeks after first study drug administration.
• 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

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Sandoz: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, Egypt

Location

Related Links

• International conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline Q2B. Guidelines for Validation of Analytical Procedures: Methodology. November, 1996

MeSH Terms

Interventions

montelukast

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2015
• First Posted: June 24, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

EG (1)