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

This study has been completed.
Sponsor:
Information provided by:
Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01418534
First received: August 11, 2011
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Torrent's Isosorbide Mononitrate 120 mg ER Tablets
 Phase 1

Study Type: Interventional
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Torrent Pharmaceuticals Limited:

Primary Outcome Measures:
  • bioequivalence based on Composite of Pharmacokinetics [ Designated as safety issue: No ]
    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.


  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418534

Locations
India
Trident Life sciences Limited
Hyderabad, AP, India, 500050
Trident Life Sciences Limited
Hydrabad, AP, India, 500050
Sponsors and Collaborators
Torrent Pharmaceuticals Limited
  More Information

No publications provided

Responsible Party: Chief Investigator, Torrent Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01418534     History of Changes
Other Study ID Numbers: 179/09
Study First Received: August 11, 2011
Last Updated: August 16, 2011
Health Authority: India: Drugs Controller General of India
India: Indian Council of Medical Research

Additional relevant MeSH terms:
Isosorbide
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013