Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions
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
1 other identifier
interventional
N/A
1 country
2
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
Trial Health
Trial Health Score
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2011
CompletedFirst Posted
Study publicly available on registry
August 17, 2011
CompletedAugust 17, 2011
August 1, 2011
August 11, 2011
August 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Trident Life sciences Limited
Hyderabad, Andhra Pradesh, 500050, India
Trident Life Sciences Limited
Hydrabad, Andhra Pradesh, 500050, India
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 11, 2011
First Posted
August 17, 2011
Last Updated
August 17, 2011
Record last verified: 2011-08