Bioequivalence Study of Torrent Pharmaceutical Limited's ISMN 120 mg ER Tablets Under Fasting Condition

An Open Label, Randomized, Two Treatment, Two Sequence, Two Period, Cross-over, Single-dose Comparative Oral Bioavailability Study of Isosorbide Mononitrate 120 mg ER Tablets (Test) of Torrent Pharmaceuticals Ltd., India and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA in Healthy, Adult, Male, Human Subjects Under Fasting Conditions

Objective:

to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA. Dosing periods were separated by a washout period of 8 days.

Study Design:

randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Torrent's Isosorbide Mononitrate 120 mg ER Tablets

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • AP
    • Hyderabad, AP, India, 500050
      • Trident Life Sciences Limited
    • Hydrabad, AP, India, 500050
      • Trident Life Sciences Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
bioequivalence based on Composite of Pharmacokinetics	bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.

Collaborators and Investigators

• Sponsor: Torrent Pharmaceuticals Limited

Study record dates

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Estimate): August 17, 2011
• Last Update Submitted That Met QC Criteria: August 16, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Nitric Oxide Donors; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: 179/09