HealthyPhase 1NCT02479854
Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck)
A Phase 1 study testing Asmakast and Singulair in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.
Trial summary
Comparative randomized, single dose, two-way crossover open-label study To investigate the bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg chewable tablets(Merck \& Co. Inc. ), after a single oral dose administration of each to healthy adults under fasting conditions, Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Asmakast and Singulair
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck) to Healthy Adult Volunteers Conditions.
Comparative randomized, single dose, two-way crossover open-label study To investigate the bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg chewable tablets(Merck \& Co. Inc. ), after a single oral dose administration of each to healthy adults under fasting conditions,
Read the 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 postdose , 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.
- Conditions
- Healthy
- Being tested
- Asmakast, Singulair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsmakastDrug
Also called Singulair
1 chewable tablet contains 5 mg montelukast
SingulairDrug
1 chewable tablet contains 5 mg montelukast
| Study group | Role | What they receive |
|---|---|---|
| A Test | Experimental | test drug (Asmakast)1 chewable tablet contains 5 mg Montelukast Receives: Drug: Asmakast |
| B Reference | Active comparator | reference drug (Singulair) 1 chewable tablet contains 5 mg Montelukast Receives: Drug: Singulair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hour
Secondary outcomes (1)
Time of the maximum plasma concentration (tmax)measurable concentration (t)
If the Tmax occurs at more than time point, then tmax will be considered for the first occurrence.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genuine Research Center, Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sandoz
- Responsible party
- Sponsor
- Investigators
- Ahmed Elshafeey, Ph.D. Pharma, Study director, Genuine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479854
- Sponsor's protocol ID
- GRC/1/14/520
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck) to Healthy Adult Volunteers Conditions.
- ClinicalTrials.gov ID
- NCT02479854
- Acronym / sponsor ID
- GRC/1/14/520
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Genuine Research Center, EgyptIndustry (pharma, biotech, devices)
- Collaborators
- Sandoz
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative randomized, single dose, two-way crossover open-label study To investigate the bioequivalence of Montelukast from 5 mg chewable tablets(Sandoz, Egypt) and Singulair5 mg chewable tablets(Merck \& Co. Inc. ), after a single oral dose administration of each to healthy adults under fasting conditions,
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 postdose , 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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Test | Experimental | Drug: Asmakasttest drug (Asmakast)1 chewable tablet contains 5 mg Montelukast |
| B Reference | Active comparator | Drug: Singulairreference drug (Singulair) 1 chewable tablet contains 5 mg Montelukast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsmakastAlso: Singulair1 chewable tablet contains 5 mg montelukast | Drug | A Test |
| Singulair1 chewable tablet contains 5 mg montelukast | Drug | B Reference |
Primary outcome
Maximal measured plasma concentration (Cmax)
Time frame: 24 hour
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
1 secondary outcome
Time of the maximum plasma concentration (tmax)measurable concentration (t)
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- The fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Related Topics. EURACHEM Guide, 1998Link provided by the sponsor.
- 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, 1996Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elshafeey, Ph.D. Pharma study director
Genuine Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Asmakast and Singulair in people with Healthy, run by Genuine Research Center, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal measured plasma concentration (Cmax) (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.