Bioequivalence Study of Sumatriptan 100mg Tablets Under Fed Conditions

NCT00872274 | Completed DMC

• 1 other identifier: 220_SUMAT_08
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of Ranbaxy Sumatriptan 100mg tablets under fed conditions

Study Arms (2)

1

EXPERIMENTAL

sumatriptan succinate tablets 100 mg (containing sumatriptan succinate equivalent to 100 mg of sumatriptan) manufactured by OHM Laboratories In

Drug: sumatriptan 100mg

2

ACTIVE COMPARATOR

IMITREX® 100 mg tablets (containing sumatriptan succinate equivalent to 100 mg of sumatriptan)

Drug: sumatriptan 100mg

Interventions

sumatriptan 100mg DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Were in the age range of 18-45 years.
• Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
• Had voluntarily given written informed consent to participate in this study.
• 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.
• Had a non-vegetarian diet habit.

You may not qualify if:

• Hypersensitivity to Sumatriptan or related group of drugs or to any other drug.
• History of interment chest pain and or chest tightness which might or might not require medication for relieve.
• History of headache, vertigo, dizziness with or without nausea vomiting
• History of intermittent loss of vision
• History of seizure and or head injury.
• 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)
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma, head-injury or coma.
• History of any psychiatric illness, which might impair the ability to provide written informed consent.
• Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• 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.
• Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
• 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.
• Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
• Clinically abnormal ECG or Chest X-ray.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy CPU

Noida, Uttar Pradesh, 201 301, India

Location

Related Links

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MeSH Terms

Interventions

Sumatriptan

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 31, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

IN (1)