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

Status:

COMPLETED

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

Lead Sponsor:

Torrent Pharmaceuticals Limited

Conditions:

Healthy

Eligibility:

MALE

18-55 years

Phase:

PHASE1

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...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01418547

Last Update

August 17 2011

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

Trident Life sciences Limited

Hyderabad, Andhra Pradesh, India, 500050