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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Torrent's Isosorbide Mononitrate 120 mg ER Tablets
Sponsored by
Torrent Pharmaceuticals Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Trident Life sciences Limited
  • Trident Life Sciences Limited

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2011
Last Updated
August 16, 2011
Sponsor
Torrent Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01418547
Brief Title
Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions
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 Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Torrent Pharmaceuticals Limited

4. Oversight

5. Study Description

Brief Summary
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 under fed condition. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Torrent's Isosorbide Mononitrate 120 mg ER Tablets
Primary Outcome Measure Information:
Title
Bioequivalence based on Composite of Pharmacokinetics
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Trident Life sciences Limited
City
Hyderabad
State/Province
AP
ZIP/Postal Code
500050
Country
India
Facility Name
Trident Life Sciences Limited
City
Hydrabad
State/Province
AP
ZIP/Postal Code
500050
Country
India

12. IPD Sharing Statement

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

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