HealthyPhase 1NCT01418534
Bioequivalence Study of Torrent Pharmaceutical Limited's ISMN 120 mg ER Tablets Under Fasting Condition
A Phase 1 study testing Torrent's Isosorbide Mononitrate 120 mg ER Tablets in people with Healthy, run by Torrent Pharmaceuticals Limited at 2 sites in India.
Trial 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. Dosing periods were separated by a washout period of 8 days. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Torrent's Isosorbide Mononitrate 120 mg ER Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 2 sitesIndia
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Trident Life sciences Limited
Hyderabad, Andhra Pradesh, 500050
Trident Life Sciences Limited
Hydrabad, Andhra Pradesh, 500050
About this study
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
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
- Conditions
- Healthy
- Being tested
- Torrent's Isosorbide Mononitrate 120 mg ER Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torrent's Isosorbide Mononitrate 120 mg ER TabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418534
- Sponsor's protocol ID
- 179/09
- Status last verified
- Aug 2011
- First submitted
- 11 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01418534
- Acronym / sponsor ID
- 179/09
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Torrent's Isosorbide Mononitrate 120 mg ER Tablets | Drug | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Torrent's Isosorbide Mononitrate 120 mg ER Tablets in people with Healthy, run by Torrent Pharmaceuticals Limited at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bioequivalence based on Composite of Pharmacokinetics. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2011.