Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions

Launched by TORRENT PHARMACEUTICALS LIMITED · Aug 16, 2011

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy males within the age range of 18 to 55 years.
• • A body mass index within 18-25 Kg/m2.
• • Given written informed consent to participate in the study.
• • Absence of diseases markers of HIV 1 \& 2, Hepatitis B \& C virus and RPR.
• • Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
• • A normal 12-lead ECG.
• • A normal chest X-Ray.
• • Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.
• • No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
• • No history of allergic rash.
• • No history of significant systemic diseases.
• • No history of psychiatric disorders or addiction to any recreational drug or drug dependence.
• • No donation of blood within 56 days prior to study check-in.
• • No participation in any clinical study within the past 56 days.
• • No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.
• • No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
• • No family history of neurological disorders.
• • Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.
• • Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.
• • Not consumed grape fruit juice within the 48 hours prior to study check-in.
• Exclusion Criteria:
• • Blood pressure Systolic\> 140 mm Hg and \< 110 mm Hg Diastolic\< 70 mm Hg \> 90 mm Hg
• • History of seizures
• • History of alcohol consumption for more than 2 units/day.
• • High caffeine or tobacco consumption
• • History of difficulty with donating blood or difficulty in accessibility of veins.
• • Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.
• • Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study