Bioequivalence Study of Sumatriptan 100mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00872924
First received: March 27, 2009
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

An open label, bioequivalence study of sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) under fasting Conditions


Condition Intervention
Healthy
Drug: sumatriptan 100mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open Label, Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets (Containing 140 mg of Sumatriptan Succinate Equivalent to 100 mg Sumatriptan) Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence evaluation of Ranbaxy Sumatriptan 100mg tablets under fasting conditions [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sumatriptan succinate 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) of OHM laboratories Inc. (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA).
Drug: sumatriptan 100mg
Active Comparator: 2
IMITREX® 100 mg tablets (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan)
Drug: sumatriptan 100mg

Detailed Description:

The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Sumatriptan Succinate Tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg sumatriptan) manufactured by OHM Laboratories Inc. with IMITREX® tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg sumatriptan) manufactured by GlaxoSmithkline Research Triangle Park, NC 27709, Made in Canada in healthy, adult, male, human subjects under fasting condition.

Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate tablets 100 mg (containing 140 mg of sumatriptan succinate equivalent to 100 mg sumatriptan) of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and supervision of trained study personnel.

32 subjects were enrolled into the study. However, twenty seven (27) subjects completed both the periods of the study. Pharmacokinetic and Statistical analysis was performed on twenty seven subjects (27) subjects.

  Eligibility

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

Inclusion Criteria:

  1. Were in the age range of 18-45 years.
  2. Were neither overweight nor underweight for their height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  3. Had voluntarily given written informed consent to participate in this study.
  4. Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria:

  1. Had history of known hypersensitivity to Sumatriptan or related group of drugs or to any other drug.
  2. Had history of intermittent chest pain and or chest tightness which might or might not require medication for relief.
  3. Had history of peripheral vascular disease (cramping, tiredness and or severe pain on walking relatively shorter distances persisting on rest, noticeable change in color (blueness or paleness) or temperature (coolness) when compared to the other limb).
  4. Had history of headache, vertigo, dizziness with or without nausea vomiting.
  5. Had history of intermittent loss of vision.
  6. Had history of seizure and or head injury.
  7. Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  8. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  9. Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for hemoglobin, total white blood cells count, differential WBC count or platelet count.
  10. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
  11. Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  12. Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
  13. Had clinically abnormal ECG or Chest X-ray.
  14. Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma head-injury or coma.
  15. Had history of any psychiatric illness which might impair the ability to provide written informed consent.
  16. Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
  17. Had history of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
  18. Used of any enzyme modifying drugs within 30 days prior to Day 1 of the study.
  19. Participation in any clinical trial within 12 weeks preceding Day 1 of the study.
  20. Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
  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: NCT00872924

Locations
India
Ranbaxy CPU
Noida,, Uttar Pradesh, India, 201 301
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00872924     History of Changes
Other Study ID Numbers: 219_SUMAT_08
Study First Received: March 27, 2009
Last Updated: March 30, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by Ranbaxy Inc.:
Bioequivalence

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 October 02, 2014