Healthy AdultsPhase 1NCT03898193
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
A Phase 1 study testing Montelukast and Singulair in people with Healthy Adults, run by Pharmtechnology LLC at 1 site in Russia.
Trial summary
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period of the study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Montelukast and Singulair
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteRussia
- Study dates
- 23 Mar 2019to 8 Apr 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy caucasian men or women aged between 18 to 45 years
- Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies
- Body mass index 18.5-30 kg/m² with body mass >45 kg and ≤100 kg
- Non-breastfeeding women
- Non-pregnant women (negative pregnancy test)
- If subject is a female and is of childbearing potential, she should practice an acceptable non-hormonal method of birth control for the duration of the study (the entire time from the moment of signing the informed consent form and within 14 days after the completion of the study), such as a combination of male condom and diaphragm with spermicide, the use of which has begun at least 30 days before the start of participation in the study
- If subject is a male and has a female partner of childbearing potential, he should be practicing an acceptable method of birth control for the duration of the study (the entire time from the moment of signing the informed consent form and within 14 days after the completion of the study), such as a double barrier method of birth control or sexual continence during the whole study and within 14 days after completion of the study
- Subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations
Who cannot join
- Subjects with a known history of allergic disorders
- Hypersensitivity to montelukast or to any of the excipients of the test and the reference product
- Subjects with a known history of drug intolerance
- Dehydration due to diarrhea, vomiting, or another cause in the last 24 hours before the beginning of the first period of the study
- Subjects with history of psychiatric disorders
- History of convulsions, epilepsy and any other neurological disorders
Show all 34Show fewer
- Adherence to any low sodium diet for 2 weeks before starting research, or adherence to a special diet (for example, vegetarian, vegan, with restriction of the use of salt) or lifestyle (work at night, extreme physical exertion)
- Use of gestagen-containing injectable hormonal contraceptives, implants, intrauterine hormonal therapeutic systems within 6 months prior to start of the study
- Female subjects of childbearing potential having unprotected intercourse with an unsterilized male partner within 30 days prior to start of the study
- Consumption of xanthine-containing foods and drinks (tea, coffee, coca-cola, chocolate) within 72 hours prior to start of the first period of the study
- Consumption of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including cranberry juice and other cranberry drinks) within 14 days prior to start of the study
- Acute and chronic cardiovascular, respiratory, gastrointestinal diseases, neuroendocrine disorders, renal and/or hepatic impairment, blood system disorders
- Other conditions which, according to the researcher's judgment, may affect absorption, distribution, biotransformation and elimination of any formulation or increase risks of deterioration of volunteer's condition
- Surgical interventions on the gastrointestinal tract with the exception of appendectomy
- Acute infectious diseases less than 4 weeks prior to the start of the study
- ECG abnormalities
- Sitting systolic blood pressure < 100 mm Hg or > 130 mm Hg and/or sitting diastolic blood pressure < 70 mm Hg or > 90 mm Hg
- Heart rate <60 or >80 beats per minute at screening check-in
- Use of liver enzyme inducers and inhibitors, in particular isoenzyme CYP3A4 (inducers: omeprazole, cimetidine, products containing the extract of Hypericum perforatum, barbiturates, carbamazepine, phenytoin, glucocorticoids; inhibitors: antiviral drugs, clarithromycin, ciprofloxacin, gestodene etc.) within 2 months prior to the start of the study
- Use of any systemic drugs within 14 days prior to the start of the study
- Use of Over-The-Counter (OTC) drugs, including herbs and nutritional supplements within 7 days prior to the First Dosing Date (including vitamins and natural food additives, phyto supplements,herbal preparations such as, cat's claw, angelica officinalis, oenothera, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng)
- Donation of plasma or blood (450 ml or more) within 2 months prior to the start of the study
- Intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml dry wine or 50 ml of spirits) or history of alcoholism, drug addiction, drug abuse
- Intake of more than 10 units alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml dry wine or 50 ml of spirits) or history of alcoholism, drug addiction, drug abuse
- Smoking more than 10 cigarettes per day
- Participation in other clinical trials of medicines within 3 months prior to the start of the study
- Positive test for syphilis, hepatitis B, hepatitis C or HIV
- Positive pregnancy test (for female subjects with childbearing potential)
- Breast-feeding
- In the case of using of oral hormonal contraceptives, they should be withdrawn 2 months prior to the start of the study
- Positive test for alcohol in exhaled air
- Positive urinary screen test for the content of narcotic and potent substances during screening and at each arrival at the research stage
- The values of standard laboratory and instrumental parameters that go beyond the reference values of the local clinical laboratory for laboratory parameters and the conventional reference values for instrumental parameters
- History of phenylketonuria
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2"
Yaroslavl, Yaroslavl Oblast, 150010
About this study
Official title: Single-Dose Open-label Randomized Crossover, in Two Periods and in Two Sequences, Single-Center Comparative Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Republic of Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period of the study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Read the detailed description
The objective of this study is to establish if two formulations of montelukast are bioequivalent. Also monitoring, registration and evaluation of adverse events will be performed.
The test formulation is Montelukast, 5 mg сhewable tablets (Pharmtechnology LLC, Belarus). The reference formulation is Singulair®, 5 mg сhewable tablets (Merck Sharp \& Dohme B.V., the Netherlands). 34 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of participants (17). Each participant in a cohort will receive single tablet (5 mg of montelukast) of the test or the reference product with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list, i. e. 17 participants in each cohort will receive the test product and 17 participants in each cohort will receive the reference product in each of two periods of the study. Participants will fast 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 participants 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples will be collected withing 30 minutes before dosing and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing (total number: 20). The washout period will be 7 days.
At the bio-analytical stage, a validated High Performance Liquid Chromatography with Tandem Mass Spectrometry detection (HPLC/MS) method will be used to determine plasma concentrations of montelukast. At all stages of working with biological samples measures to protect montelukast from daylight exposure should be provided.
ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, Area Under the pharmacokinetic Curve from the beginning of the study to the time of the last measured concentration (AUC0-t) and 90% confidence interval will be constructed for the ratio of geometric means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for montelukast falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t
- Conditions
- Healthy Adults
- Being tested
- Montelukast, Singulair
- Keywords
- Bioequivalence, Montelukast, Singulair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called The test product
Montelukast, 5 mg Chewable Tablets, manufactured by Pharmtechnology LLC, Republic of Belarus
SingulairDrug
Also called The reference product
Singulair, 5 mg Chewable Tablets, marketed by Merck Sharp \& Dohme B.V., the Netherlands
| Study group | Role | What they receive |
|---|---|---|
| Sequence Test-Reference (TR) | Other | 17 participants (total number of enrolled volunteers - 34) assigned to sequence TR will receive a single 5 mg dose of the test product Montelukast (1 x 5 mg tablet) marked as T in period 1 and a single 5 mg dose of the reference product Singulair (1 x 5 mg tablet) marked as R in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Montelukast; Drug: Singulair |
| Sequence Reference-Test (RT) | Other | 17 participants (total number of enrolled volunteers - 34) assigned to sequence RT will receive a single 5 mg dose of the reference product Singulair (1 x 5 mg tablet) marked as R in period 1 and a single 5 mg dose of the test product Montelukast (1 x 5 mg tablet) marked as T in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. Receives: Drug: Montelukast; Drug: Singulair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of montelukast for the test and the reference products
Maximum concentration in plasma among observed concentrations at pre-specified time points
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
AUC0-t of montelukast for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Secondary outcomes (6)
AUC0-∞ of montelukast for the test and the reference products
Area under the plasma concentration versus time curve from time 0 to infinite time
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Tmax of montelukast for the test and the reference products
Time to maximum measured plasma concentration
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
T1/2 of montelukast for the test and the reference products
Elimination or terminal half-life
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Kel of montelukast for the test and the reference products
Elimination rate constant
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
AUCresid of montelukast for the test and the reference products
Residual area under the pharmacokinetic curve from the time of the last measured concentration to infinite time
Measured: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject will be administered an investigational product and which does not necessarily have a causal relationship with the treatment. The data from subjects who will take at least one investigational product will be analyzed.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start23 Mar 2019
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Responsible party
- Sponsor
- Investigators
- Alexander Khokhlov, Principal investigator, ClinPharmInvest, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898193
- Sponsor's protocol ID
- FRM-07-MONT v.2.1 01/29/2019
- Status last verified
- Mar 2019
- First submitted
- 29 Mar 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Open-label Randomized Crossover, in Two Periods and in Two Sequences, Single-Center Comparative Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Republic of Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03898193
- Acronym / sponsor ID
- FRM-07-MONT v.2.1 01/29/2019
- Conditions
- Healthy Adults
- Keywords
- Bioequivalence, Montelukast, Singulair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- ClinPharmInvest, LLC
- Study start
- 23 Mar 2019 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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.
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period of the study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Detailed description
The objective of this study is to establish if two formulations of montelukast are bioequivalent. Also monitoring, registration and evaluation of adverse events will be performed.
The test formulation is Montelukast, 5 mg сhewable tablets (Pharmtechnology LLC, Belarus). The reference formulation is Singulair®, 5 mg сhewable tablets (Merck Sharp \& Dohme B.V., the Netherlands). 34 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of participants (17). Each participant in a cohort will receive single tablet (5 mg of montelukast) of the test or the reference product with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list, i. e. 17 participants in each cohort will receive the test product and 17 participants in each cohort will receive the reference product in each of two periods of the study. Participants will fast 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 participants 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples will be collected withing 30 minutes before dosing and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing (total number: 20). The washout period will be 7 days.
At the bio-analytical stage, a validated High Performance Liquid Chromatography with Tandem Mass Spectrometry detection (HPLC/MS) method will be used to determine plasma concentrations of montelukast. At all stages of working with biological samples measures to protect montelukast from daylight exposure should be provided.
ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, Area Under the pharmacokinetic Curve from the beginning of the study to the time of the last measured concentration (AUC0-t) and 90% confidence interval will be constructed for the ratio of geometric means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for montelukast falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence Test-Reference (TR) | Other | Drug: Montelukast, Drug: Singulair17 participants (total number of enrolled volunteers - 34) assigned to sequence TR will receive a single 5 mg dose of the test product Montelukast (1 x 5 mg tablet) marked as T in period 1 and a single 5 mg dose of the reference product Singulair (1 x 5 mg tablet) marked as R in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
| Sequence Reference-Test (RT) | Other | Drug: Montelukast, Drug: Singulair17 participants (total number of enrolled volunteers - 34) assigned to sequence RT will receive a single 5 mg dose of the reference product Singulair (1 x 5 mg tablet) marked as R in period 1 and a single 5 mg dose of the test product Montelukast (1 x 5 mg tablet) marked as T in period 2. These treatments will be administered orally with 200 ml of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy caucasian men or women aged between 18 to 45 years
- Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments and imaging studies
- Body mass index 18.5-30 kg/m² with body mass >45 kg and ≤100 kg
- Non-breastfeeding women
- Non-pregnant women (negative pregnancy test)
Key exclusion criteria (34 listed)
- Subjects with a known history of allergic disorders
- Hypersensitivity to montelukast or to any of the excipients of the test and the reference product
- Subjects with a known history of drug intolerance
- Dehydration due to diarrhea, vomiting, or another cause in the last 24 hours before the beginning of the first period of the study
- Subjects with history of psychiatric disorders
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 |
|---|---|---|
| MontelukastAlso: The test productMontelukast, 5 mg Chewable Tablets, manufactured by Pharmtechnology LLC, Republic of Belarus | Drug | Sequence Reference-Test (RT), Sequence Test-Reference (TR) |
| SingulairAlso: The reference productSingulair, 5 mg Chewable Tablets, marketed by Merck Sharp \& Dohme B.V., the Netherlands | Drug | Sequence Reference-Test (RT), Sequence Test-Reference (TR) |
Primary outcome
Cmax of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Maximum concentration in plasma among observed concentrations at pre-specified time points
AUC0-t of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Area under the plasma concentration versus time curve from time 0 to the last measured concentration
6 secondary outcomes
AUC0-∞ of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Tmax of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
T1/2 of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Kel of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
AUCresid of montelukast for the test and the reference products
Time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
Time frame: 8 days
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 6 Jun 2019.
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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.
Alexander Khokhlov principal investigator
ClinPharmInvest, LLC
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 Montelukast and Singulair in people with Healthy Adults, run by Pharmtechnology LLC at 1 site in Russia.
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 8 inclusion and 34 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 6 Jun 2019. 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 Russia. 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?
Cmax of montelukast for the test and the reference products (time frame: Time points: 0.00 (withing 30 minutes before dosing) and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing). The study lists 2 primary outcomes in all. 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 6 Jun 2019.