Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01269281
First received: January 3, 2011
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Sumatriptan
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUCt and AUCi parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2005
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sumatriptan Succinate tablets 100 mg
Sumatriptan Succinate tablets 100 mg of Dr.Reddy's Laboratories Limited
Drug: Sumatriptan
Sumatriptan Succinate Tablets 100 mg
Other Name: Imitrex
Active Comparator: Imitrex 100 mg Tablets
Imitrex 100 mg Tablets of Glaxosmithkline
Drug: Sumatriptan
Sumatriptan Succinate Tablets 100 mg
Other Name: Imitrex

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subjects should be healthy males between 18 and 45 years.
  2. The subjects should be screened within 21 days prior to the administration of first dose of the study..
  3. The subjects should have a BMI between 18 and 25 kg/m2
  4. The subjects should be able to communicate effectively with study personnel
  5. The subjects should be literate and able to give consent
  6. 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:

  1. The subjects who have a history of allergic responses to Sumatriptan or other related drugs
  2. The subjects who have history of intake of MAOI within two weeks of dosing
  3. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses..
  4. The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG, and X-ray recordings..
  5. 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.
  6. The subjects who have a history or presence of asthma (including aspirin induced asthma) or nasal polyp..
  7. The subjects who are smokers and who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period..
  8. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins..
  9. 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).
  10. The subject who has a positive hepatitis screen including hepatitis B surface antigen, anti HCV, anti HEV.
  11. The subject who has a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
  12. 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).
  13. 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.
  14. Female volunteers demonstrating a positive pregnancy screen.
  15. Female volunteers who are currently breast- feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269281

Locations
India
BA Research India Limited
Bodakdev, Ahmedabad, India, 380 054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Roma Choudhury, MBBS BA Research India Limited
  More Information

No publications provided

Responsible Party: General Manager - Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01269281     History of Changes
Other Study ID Numbers: BA0559019
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
two way crossover

Additional relevant MeSH terms:
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014