HealthyPhase 1NCT00847405

Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions

A Phase 1 study testing Sumatriptan Succinate and Imitrex® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fasting conditions. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Sumatriptan Succinate and Imitrex®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteCanada
Study dates: Mar 2003to Mar 2003
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Non-smoking (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening) male or female within an age range of 18-40 years.
Body Mass Index (BMI = weight/height2) greater than 19 kg/m2 and less than 26 kg/m2.
Normal findings in the physical examination, vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-80 beats/min) and 12-lead ECG.
Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum β-CG).
No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.

Who cannot join

Known history of hypersensitivity to sumatriptan (e.g. Imitrex®, Imigran®) and/or related drugs such as almotriptan, naratriptan, rizatriptan and zolmitriptan
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness during the last four weeks prior to entry into this study.
Presence of any significant physical or organ abnormality.
Any subject with a history of drug abuse.

Show all 21Show fewer

Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
Use of any prescription medication within 14 days preceding entry into this study.
Use of any monoamine oxidase (MAO) inhibitor drugs such as phenelzine or tranylcypromine within 30 days preceding entry into this study.
Use of over the counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
Female subjects: presence of pregnancy or lactation.
Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
Participation in a clinical trial with an investigational drug within 30 days preceding this study.
Any subject who has donated blood within 56 days preceding this study.
Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
Significant or recent history of asthma (after 12 years of age).
Any subject with a recent (less than one year) history of alcohol abuse.
Known history of frequent headaches or migraines.
Any subject with a parental or sibling history of heart attack or stroke that occurred under the age of 40 years.
Intolerance to venipuncture.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Biovail Contract Research
Toronto, Ontario, M1L 4S4

Other trials in Canada

About this study

Official title: A Two-Way Crossover, Open-Label, Single-Dose, Fasting Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets Versus Imitrex® 100 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Sumatriptan Succinate, Imitrex®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sumatriptan SuccinateDrug
100 mg Tablets
Imitrex®Drug
100 mg Tablet

Study groups in NCT00847405
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Sumatriptan Succinate
2	Active comparator	Not described Receives: Drug: Imitrex®

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax.
Measured: Blood samples collected over a 12 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Measured: Blood samples collected over a 12 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Measured: Blood samples collected over a 12 hour period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2003Mar 2003

First posted19 Feb 2009 (estimated)
Study startMar 2003
Primary completionMar 2003
Study completionMar 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00847405
Sponsor's protocol ID: 2678
Status last verified: Sep 2009
First submitted: 17 Feb 2009
Last updated: 11 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-Way Crossover, Open-Label, Single-Dose, Fasting Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets Versus Imitrex® 100 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
ClinicalTrials.gov ID: NCT00847405
Acronym / sponsor ID: 2678
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Mar 2003
Primary completion: Mar 2003 (actual)
Study completion: Mar 2003 (actual)
First posted: 19 Feb 2009 (estimated)
Results: Posted 18 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Sumatriptan Succinate
2	Active comparator	Drug: Imitrex®

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Non-smoking (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening) male or female within an age range of 18-40 years.
Body Mass Index (BMI = weight/height2) greater than 19 kg/m2 and less than 26 kg/m2.
Normal findings in the physical examination, vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-80 beats/min) and 12-lead ECG.
Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum β-CG).
No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.

Key exclusion criteria (21 listed)

Known history of hypersensitivity to sumatriptan (e.g. Imitrex®, Imigran®) and/or related drugs such as almotriptan, naratriptan, rizatriptan and zolmitriptan
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
Any clinically significant illness during the last four weeks prior to entry into this study.
Presence of any significant physical or organ abnormality.

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
Sumatriptan Succinate100 mg Tablets	Drug	1
Imitrex®100 mg Tablet	Drug	2

Primary outcome

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 12 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 12 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 12 hour period.
Bioequivalence based on AUC0-inf.

Results and safety

Results posted to the registry on 18 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test (Sumatriptan) First	14	14
Reference (Imitrex®) First	14	13

Primary outcome: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 12 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Test (Sumatriptan) n = 26	Reference (Imitrex®) n = 26
Value	57.26 (14.45)	56.66 (20.4)

Test (Sumatriptan) vs Reference (Imitrex®): Ratio of the T/R geometric mean x 100: 103.64 (90% CI 95.93 to 111.97)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Time frame: Blood samples collected over a 12 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Test (Sumatriptan) n = 26	Reference (Imitrex®) n = 26
Value	258.76 (76.55)	252.26 (75.84)

Test (Sumatriptan) vs Reference (Imitrex®): Ratio of the T/R geometric mean x 100: 102.81 (90% CI 97.95 to 107.91)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 12 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Test (Sumatriptan) n = 26	Reference (Imitrex®) n = 26
Value	268.5 (79.84)	260.47 (78.25)

Test (Sumatriptan) vs Reference (Imitrex®): Ratio of the T/R geometric mean x 100: 103.25 (90% CI 98.35 to 108.41)

Population analysed: All participants that completed the study had their samples analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Paul Y Tam, MD principal investigator

Biovail Contract Research

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 Succinate and Imitrex® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

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 6 inclusion and 21 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 11 Sep 2009. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 12 hour period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00847405.

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 11 Sep 2009.