Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions

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.

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 fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Imitrex®; Drug: Sumatriptan Succinate

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Gateway Medical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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.

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Sumatriptan Succinate; 100 mg Tablet
Active Comparator: 2	Drug: Imitrex®; 100 mg Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	Bioequivalence based on Cmax.	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.	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.	Blood samples collected over a 12 hour period.

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Ali Ziaee, MD, Cetero Research, San Antonio

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): September 11, 2009
• Last Update Submitted That Met QC Criteria: September 1, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan
• Other Study ID Numbers: 04225