HealthyPhase 1NCT01691456
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition
A Phase 1 study testing Montelukast sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Montelukast sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2011to Feb 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must fulfill the following criteria to be considered for inclusion into this study.
- Healthy subjects within the age range of 18 to 50 years.
- A body mass index between 18.5 to 24.9 Kg/m2
- Given written informed consent to participate in the study.
- Absence of disease markers of HIV 1 \& 2, hepatitis B \& C virus and RPR.
- Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
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- A normal 12-lead ECG.
- A normal chest X-ray (PA view).
- Compliance with the requirement of the entire protocol.
- No history or no evidence of hypersensitivity to Montelukast and to any component of the formulation.
- No history of gastrointestinal problems (ulcers).
- No history of significant systemic diseases.
- No history of psychiatric disorders.
- No history of allergic rash.
- No history of addiction to any recreational drug or drug dependence.
- No donation of blood (one unit or 350 mL) within 90 days prior to study check in.
- No Participation in any clinical study within the past 90 days.
- No receipt of any prescription drugs or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations vitamins and natural products used for therapeutic benefits), within two weeks prior to study check-in.
- No history of dehydration from dialThea, vomiting or any other reason within a period of24.0 hours prior to study check-in.
- No family history of neurological disorders. Not consumed alcohol and xanthine containing food and beverages (chocolates, tea, coffee or cola drink:s), cigarettes and tobacco products, for at least 48.0 hours prior to study check-in.
- Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines, Ca1U1abinoids and Barbiturates) in urine during the day of study check-in.
- Not consumed grapefruit (mosumbi/sweet lime) juice within the 48.0 hours prior to study check-in.
- Negative alcohol breath analysis during the study check-in.
- Female volunteers demonstrating a negative pregnancy test.
- If study volunteer is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- or is postmenopausal for at least 1 year. or is surgically . sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the study volunteer).
- Exclusion Criteria The subjects were excluded based on the following criteria.
- History of seizures.
- Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
- History of alcohol consumption for more than two units/day (1 unit = 30 mL of spirit/or 1 pint of beer), or having consumed alcohol within 48 hours prior to check-in.
- High caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day) consumption.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- An unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions.
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
Read the detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral granules of Merck Sharp \& Dohme Ltd., USA in healthy, adult, human subjects under fasting conditions.
- Conditions
- Healthy
- Being tested
- Montelukast sodium
- Keywords
- Bioequivalence, Montelukast Sodium, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast sodiumDrug
Also called SINGULAIR
Montelukast Sodium Oral Granules 4mg
| Study group | Role | What they receive |
|---|---|---|
| Montelukast Sodium Oral Granules | Experimental | Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited Receives: Drug: Montelukast sodium |
| SINGULAIR | Active comparator | (Montelukast sodium) Oral Granules 4mg of Merck Sharp \& Dohme Ltd., USA Receives: Drug: Montelukast sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve(AUC)
Measured: Pre-dose (0.00) and 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionFeb 2011
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A. Jayachandra Reddy, Dr., Principal investigator, Axis Clinicals Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691456
- Sponsor's protocol ID
- 539-10
- Status last verified
- Sep 2012
- First submitted
- 20 Sep 2012
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study in Healthy, Adult, Human Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01691456
- Acronym / sponsor ID
- 539-10
- Conditions
- Healthy
- Keywords
- Bioequivalence, Montelukast Sodium, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Sep 2012 (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.
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
Detailed description
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Montelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (Montelukast sodium) 4mg oral granules of Merck Sharp \& Dohme Ltd., USA in healthy, adult, human subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast Sodium Oral Granules | Experimental | Drug: Montelukast sodiumMontelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited |
| SINGULAIR | Active comparator | Drug: Montelukast sodium(Montelukast sodium) Oral Granules 4mg of Merck Sharp \& Dohme Ltd., USA |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- Subjects must fulfill the following criteria to be considered for inclusion into this study.
- Healthy subjects within the age range of 18 to 50 years.
- A body mass index between 18.5 to 24.9 Kg/m2
- Given written informed consent to participate in the study.
- Absence of disease markers of HIV 1 \& 2, hepatitis B \& C virus and RPR.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Montelukast sodiumAlso: SINGULAIRMontelukast Sodium Oral Granules 4mg | Drug | Montelukast Sodium Oral Granules, SINGULAIR |
Primary outcome
Area under curve(AUC)
Time frame: Pre-dose (0.00) and 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.
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 Sep 2012.
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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.
A. Jayachandra Reddy, Dr. principal investigator
Axis Clinicals Limited
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 sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 33 inclusion and 0 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 Sep 2012. 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 India. 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?
Area under curve(AUC) (time frame: Pre-dose (0.00) and 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.). 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 Sep 2012.