Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00846885
• Date of registration: 17/02/2009
• Primary sponsor: Teva Pharmaceuticals USA
• Public title: Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions
• Scientific title: A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Sumatriptan Succinate, (100mg), Compared to and Equivalent Dose of a Commercially Available Reference Drug Product (Imitrex®, GlaxoSmithKline, USA) in 28 Fed, Healthy, Adult Subjects.
• Date of first enrolment: August 2004
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00846885
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

Canada, United States

Contacts

• Name: Ali Ziaee, MD
• Affiliation: Cetero Research, San Antonio

Key inclusion & exclusion criteria

Inclusion Criteria

- 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 ß-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.

Exclusion Criteria

- 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.

- 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Imitrex®

Drug: Sumatriptan Succinate

Primary Outcome(s)

AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [Time Frame: 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) [Time Frame: Blood samples collected over a 12 hour period.]

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [Time Frame: Blood samples collected over a 12 hour period.]

Secondary ID(s)

04225

Source(s) of Monetary Support

Please refer to primary and secondary sponsors