- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269281
Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
January 3, 2011 updated by: Dr. Reddy's Laboratories Limited
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ahmedabad
-
Bodakdev, Ahmedabad, India, 380 054
- BA Research India Limited
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 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).
Exclusion Criteria:
- 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..
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sumatriptan Succinate tablets 100 mg
Sumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited
|
Sumatriptan Succinate Tablets 100 mg
Other Names:
|
Active Comparator: Imitrex 100 mg Tablets
Imitrex 100 mg Tablets of Glaxosmithkline
|
Sumatriptan Succinate Tablets 100 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on Cmax and AUCt and AUCi parameters
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roma Choudhury, MBBS, BA Research India Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
January 3, 2011
First Submitted That Met QC Criteria
January 3, 2011
First Posted (Estimate)
January 4, 2011
Study Record Updates
Last Update Posted (Estimate)
January 4, 2011
Last Update Submitted That Met QC Criteria
January 3, 2011
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA0559019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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