HealthyPhase 1NCT01269281
Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
A Phase 1 study testing Sumatriptan in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sumatriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2005to Jul 2005
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects should be healthy males between 18 and 45 years.
- The subjects should be screened within 21 days prior to the administration of first dose of the study..
- The subjects should have a BMI between 18 and 25 kg/m2
- The subjects should be able to communicate effectively with study personnel
- The subjects should be literate and able to give consent
- If subject is a female volunteer and
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- 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
- Is postmenopausal for at least 1 year
- Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Who cannot join
- The subjects who have a history of allergic responses to Sumatriptan or other related drugs
- The subjects who have history of intake of MAOI within two weeks of dosing
- The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses..
- The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings..
- The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or glaucoma or any other body system.
- The subjects who have a history or presence of asthma (including aspirin induced asthma) or nasal polyp..
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- The subjects who are smokers and who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period..
- The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins..
- The subjects who have donated 01 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication (if blood loss is below or equal to 200mL, subjects can be enrolled in the trial after 60 days of donation).
- The subject who has a positive hepatitis screen including hepatitis B surface antigen, anti HCV, anti HEV.
- The subject who has a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
- The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration (elimination half-life of study drug should be taken into consideration for inclusion of subject in the trial if blood loss is below or equal to 200 mL).
- An unusual diet, for whatever reason (e .g. low sodium) for four weeks prior to receiving the study medication and throughout the subject's participation in the study.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breast- feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized, Two Way Crossover, Comparative Evaluation of Relative Bioavailabilities of Two Formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories Limited, India)With the Reference Formulation Imitrex Tablets 100 mg (Glaxosmilthkine) in Healthy Adult Subjects Under Fed Conditions.
The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects.
Read the detailed description
Open Label, Randomized, Two way crossover, comparative evaluation of relative bioavailability of two formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation Imitrex® 100 mg Tablet (Glaxosmithkline, USA)Under Fed Conditions in Healthy Human Adult Subjects. 50 healthy, adult, human male subjects were enrolled in the study and 43 subjects are completed the study.
- Conditions
- Healthy
- Being tested
- Sumatriptan
- Keywords
- Bioequivalence, two way crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumatriptanDrug
Also called Imitrex
Sumatriptan Succinate Tablets 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Sumatriptan Succinate tablets 100 mg | Experimental | Sumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited Receives: Drug: Sumatriptan |
| Imitrex 100 mg Tablets | Active comparator | Imitrex 100 mg Tablets of Glaxosmithkline Receives: Drug: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUCt and AUCi parameters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startJul 2005
- Primary completionJul 2005
- Study completionJul 2005
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roma Choudhury, MBBS, Principal investigator, BA Research India Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269281
- Sponsor's protocol ID
- BA0559019
- Status last verified
- Oct 2005
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Two Way Crossover, Comparative Evaluation of Relative Bioavailabilities of Two Formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories Limited, India)With the Reference Formulation Imitrex Tablets 100 mg (Glaxosmilthkine) in Healthy Adult Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01269281
- Acronym / sponsor ID
- BA0559019
- Conditions
- Healthy
- Keywords
- Bioequivalence, two way crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 4 Jan 2011 (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.
The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects.
Detailed description
Open Label, Randomized, Two way crossover, comparative evaluation of relative bioavailability of two formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation Imitrex® 100 mg Tablet (Glaxosmithkline, USA)Under Fed Conditions in Healthy Human Adult Subjects. 50 healthy, adult, human male subjects were enrolled in the study and 43 subjects are completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sumatriptan Succinate tablets 100 mg | Experimental | Drug: SumatriptanSumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited |
| Imitrex 100 mg Tablets | Active comparator | Drug: SumatriptanImitrex 100 mg Tablets of Glaxosmithkline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subjects should be healthy males between 18 and 45 years.
- The subjects should be screened within 21 days prior to the administration of first dose of the study..
- The subjects should have a BMI between 18 and 25 kg/m2
- The subjects should be able to communicate effectively with study personnel
- The subjects should be literate and able to give consent
Key exclusion criteria (15 listed)
- The subjects who have a history of allergic responses to Sumatriptan or other related drugs
- The subjects who have history of intake of MAOI within two weeks of dosing
- The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses..
- The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings..
- The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or glaucoma or any other body system.
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 |
|---|---|---|
| SumatriptanAlso: ImitrexSumatriptan Succinate Tablets 100 mg | Drug | Imitrex 100 mg Tablets, Sumatriptan Succinate tablets 100 mg |
Primary outcome
Bioequivalence based on Cmax and AUCt and AUCi parameters
Time frame: 4 months
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 4 Jan 2011.
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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.
Roma Choudhury, MBBS principal investigator
BA Research India 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 Sumatriptan 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 9 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 4 Jan 2011. 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?
Bioequivalence based on Cmax and AUCt and AUCi parameters (time frame: 4 months). 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 4 Jan 2011.