Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
This study has been completed.
Information provided by:
Teva Pharmaceuticals USA
First received: February 17, 2009
Last updated: September 1, 2009
Last verified: September 2009
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.
Drug: Sumatriptan Succinate
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
||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
Primary Outcome Measures:
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 12 hour period. ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2003 (Final data collection date for primary outcome measure)
Drug: Sumatriptan Succinate
100 mg Tablets
Active Comparator: 2
100 mg Tablet
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00847405
|Biovail Contract Research
|Toronto, Ontario, Canada, M1L 4S4 |
Teva Pharmaceuticals USA
||Paul Y Tam, MD
||Biovail Contract Research
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 17, 2009
|Results First Received:
||July 6, 2009
||September 1, 2009
||Canada: Ethics Review Committee
Keywords provided by Teva Pharmaceuticals USA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2014
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