Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00872274
First received: March 27, 2009
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

To access the single-dose oral bioequivalence of sumatriptan succinate 100 mg tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of OHM Laboratories Inc. (a subsidiary of Ranbaxy Pharmaceutical Inc. USA) with IMITREX® 100 mg tablet (containing 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan) of GlaxoSmithKline in healthy, adult, male, human subjects under fed condition.


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 Fed 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 fed 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 tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by OHM Laboratories In
Drug: sumatriptan 100mg
Active Comparator: 2
IMITREX® 100 mg tablets (containing sumatriptan succinate equivalent to 100 mg of 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 of sumatriptan) manufactured by OHM Laboratories Inc. with IMITREX® 100 mg tablets (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by GlaxoSmithKline Research Triangle Park NC 27709, Made in Canada in healthy, adult, male, human, subjects under fed conditions.

Following an overnight fast of at least 10 hour, a single oral dose of sumatriptan succinate tablets 100 mg 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 supervision of trained study personnel 30 min after start of a high fat high calorie breakfast.

Thirty-two 32 subjects were enrolled into the study. Twenty-four (24) subjects completed both the periods of the study.

Pharmacokinetic and statistical analyses were performed on data from 24 subjects who completed both the periods of 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. Were in the age range of 18-45 years.
  2. Were neither overweight nor underweight for his 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.
  5. Had a non-vegetarian diet habit.

Exclusion Criteria:

  1. Hypersensitivity to Sumatriptan or related group of drugs or to any other drug.
  2. History of interment chest pain and or chest tightness which might or might not require medication for relieve.
  3. History of headache, vertigo, dizziness with or without nausea vomiting
  4. History of intermittent loss of vision
  5. History of seizure and or head injury.
  6. 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)
  7. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  8. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma, head-injury or coma.
  9. History of any psychiatric illness, which might impair the ability to provide written informed consent.
  10. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  11. Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
  12. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
  13. 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.
  14. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), glucose (positive) or protein (positive).
  15. Clinically abnormal ECG or Chest X-ray.
  16. Regular smokers who smoked more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  17. 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. Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
  19. Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
  20. Subjects who, through completion of this study, would had 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: NCT00872274

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: NCT00872274     History of Changes
Other Study ID Numbers: 220_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 July 24, 2014