BioequivalencePhase 1NCT03557580

A Bioequivalence Study of Isosorbide-5-Mononitrate Extended-Release Tablets Under Fed Conditions in Healthy Subjects

A Phase 1 study testing IS-5-MN R, IS-5-MN T1 and IS-5-MN T2 in people with Bioequivalence, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this trial is to compare the pharmacokinetic characteristics of two isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd and ISMO Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg, distributed by RIEMSER Pharma GmbH. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence
What is being tested?: IS-5-MN R, IS-5-MN T1 and IS-5-MN T2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 17 Apr 2018to 18 May 2018
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects should read, sign, and date an Informed Consent Form under the premise of fully understanding of this study including risks and requirements; are unable to follow the rules of this study, prior to any study procedures;
Healthy male or non-pregnant, non-lactating female of age between 18 to 50 years (both inclusive);
Body weight ≥ 50 kg for male and 45 kg for female, body mass index (BMI) within 19.0-25.0 Kg/m2;
Subject (including male subject) has no fertility plan within the future 3 months and take reliable contraceptive (physical);
Subject must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception from screening until 3 months after last dose of study drug;
Subject is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgment of the investigator.

Who cannot join

Subject has allergic constitution or hypersensitivity to the active substance or to isosorbide dinitrate, or rare hereditary problems of galactose intolerance or fructose intolerance, the Lapp lactase deficiency, glucose - galactose malabsorption or sucrase - isomaltase insufficiency.
Subject has dysphagia or any disorder that may interfere with drug absorption, distribution, metabolism, or excretion, e.g. gastrointestinal, liver, kidney conditions.
Subject has alcoholism history or drank excessive alcohol within 6 months prior to the study (who drinking more than 21 units of alcohol per week, 1 unit = 360 mL beer (5%) = 45 mL spirit (40%) = 150 mL red-wine (12%)), positive test results for breath alcohol test at baseline, or cannot stop alcohol intake during study.
Subject smoking more than 5 cigarettes/nicotine-containing products a day within 3 months prior to screening, or refusing to abstain from smoking or consumption of tobacco products during the study.
Subject has significant change in diet or exercise habits within 3 months prior to screening.
Subject has any food restrictions or intolerance.

Show all 21Show fewer

Subject has hospitalization history or surgery within 3 months prior to screening.
Subject has made a blood donation or had a comparable blood loss (>400ml) within 3 months prior to screening.
Subject has participated in another study of an investigational medication within the last 3 months, or taking any drugs known to have a well established toxic potential to major organs within 3 months prior to study administration.
Subject with clinically significant blood, kidneys, endocrine, gastrointestinal, respiratory, cardiovascular, hepatic, psychiatric, immunological and neurological disease.
Subject in cases of marked low blood pressure (BP ≤ 90 mmHg systolic), aortic/mitral valve stenosis, severe anaemia, glaucoma, or using a phosphodiesterase 5 inhibitor.
Subject has history of drug abuse within the past 5 years, using any recreational drugs within 3 months prior to screening, or positive test results for urine drug scan.
Female subject in lactation period, or has positive pregnancy test result, or had unprotected sexual intercourse within 14 days prior to first drug administration, or refusing to take non-pharmacological contraception (such as condoms, intrauterine devices, contraceptive rings, ligation, etc.).
Subject with clinically significant positive test results for: HIV, Hepatitis B surface antigen, Hepatitis C antibody or treponema pallidum.
Subject used any drugs known to induce or inhibit hepatic drug metabolism within 28 days prior to study administration.
Subject has any prescription medication or over the counter within the 14 days prior to study administration.
Subject using caffeine or any other beverages or foods that might affect drug absorption, metabolism or excretion, include coffee, tea, coke, chocolate, Animal viscera, dragon fruit, mango, grapefruit, grapefruit beverages or foods, etc. beginning 48 hours before each study medication administration through each study confinement period.
Subject took any vitamins or herbal medicines (includes herbs in the diet) beginning 48 hours before each study medication administration through each study confinement period.
Subject has any illness during the screening stage.
Subject has history of blood phobia or belonephobia.
Subject has any condition, according to investigator's best judgement, that prevents the subject to participate in the trial, or unable to adhere with restrictions detailed in the informed consent or protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

Qingyuan People's Hospital
Qingyuan

Other trials in China

About this study

Official title: A Randomized, Open Label, Balanced, Single Dose, 3-way Crossover Bioequivalence Study of Two Isosorbide -5 -Mononitrate Extended -Release Tablets 40 mg and ISMO Retard 40 mg Under Fed Conditions in Healthy Subjects

Primary endpoints are Cmax, AUC(0-t) and AUC(0-inf). Secondary endpoints are Tmax, t1/2 and λz.

Read the detailed description

Objectives: Primary Objective: To compare the pharmacokinetic characteristics of two isosorbide -5 -mononitrate extended -release tablets 40 mg of Qilu Pharmaceutical Co., Ltd, China and ISMO Retard (isosorbide -5 -mononitrate extended -release tablet) 40 mg, distributed by RIEMSER Pharma GmbH. following a single oral dose administration in healthy Chinese subjects under fed condition.

Secondary Objective: To monitor the safety profile of the subjects exposed to the Investigational Medicinal Product.

Study Design: a randomized, open label, balanced, 3-way crossover, single dose study under fed conditions.12 subjects will be randomized to one of the 3 treatment sequences. Each treatment sequence will consist of 3 periods, separated by a washout period of at least 7 days. For sequence 1, first reference drug, then test formulation 1 and test formulation 2 will be administered. The order for sequence 2 is test formulation 2, reference drug and test formulation 1. The order for sequence 3 is test formulation 1, test formulation 2 and reference drug.

Conditions: Bioequivalence
Being tested: IS-5-MN R, IS-5-MN T1, IS-5-MN T2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IS-5-MN RDrug
Also called ISMO Retard, IS-5-MN
single orally dose under fed conditions on day 1 of treatment period 1 for group 1, on day 1 of treatment period 2 for group 2, on day 1 of treatment period 3 for group 3.
IS-5-MN T1Drug
Also called IS-5-MN
single orally dose under fed conditions on day 1 of treatment period 2 for group 1, on day 1 of treatment period 3 for group 2, on day 1 of treatment period 1 for group 3.
IS-5-MN T2Drug
Also called IS-5-MN
single orally dose under fed conditions on day 1 of treatment period 3 for group 1, on day 1 of treatment period 1 for group 2, on day 1 of treatment period 2 for group 3.

Study groups in NCT03557580
Study group	Role	What they receive
IS-5-MN R	Active comparator	Isosorbide-5-mononitrate extended-release tablet, Single oral dose 40mg Receives: Drug: IS-5-MN R
IS-5-MN T1	Experimental	Isosorbide-5-mononitrate extended-release tablet, Single oral dose 40mg Receives: Drug: IS-5-MN T1
IS-5-MN T2	Experimental	Isosorbide-5-mononitrate extended-release tablet, Single oral dose 40mg Receives: Drug: IS-5-MN T2

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum plasma Capecitabine concentration
Measured: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
AUC0-t
The area under the plasma concentration time curve from zero to the last measurable concentration.
Measured: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
AUC0-∞
The area under the plasma concentration time curve from zero to infinity.
Measured: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose

Secondary outcomes (3)

Tmax
Time of the maximum measured plasma concentration
Measured: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
Kel
The elimination rate constant associated with the terminal (log-linear) portion of the curve. Estimated by linear regression of time vs. log concentration.
Measured: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
t½
The terminal elimination half-life calculated by 0.693/Kel.
Measured: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201818 May 2018

First posted15 Jun 2018
Study start17 Apr 2018
Primary completion6 May 2018
Study completion18 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BioequivalenceStudies of the same condition, open and under way.
More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03557580
Sponsor's protocol ID: QL-YK1-039-Y01
Status last verified: Jun 2018
First submitted: 4 Jun 2018
Last updated: 15 Jun 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Balanced, Single Dose, 3-way Crossover Bioequivalence Study of Two Isosorbide -5 -Mononitrate Extended -Release Tablets 40 mg and ISMO Retard 40 mg Under Fed Conditions in Healthy Subjects
ClinicalTrials.gov ID: NCT03557580
Acronym / sponsor ID: QL-YK1-039-Y01
Conditions: Bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 17 Apr 2018 (actual)
Primary completion: 6 May 2018 (actual)
Study completion: 18 May 2018 (actual)
First posted: 15 Jun 2018 (actual)
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.

Primary endpoints are Cmax, AUC(0-t) and AUC(0-inf). Secondary endpoints are Tmax, t1/2 and λz.

Detailed description

Secondary Objective: To monitor the safety profile of the subjects exposed to the Investigational Medicinal Product.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
IS-5-MN R	Active comparator	Drug: IS-5-MN RIsosorbide-5-mononitrate extended-release tablet, Single oral dose 40mg
IS-5-MN T1	Experimental	Drug: IS-5-MN T1Isosorbide-5-mononitrate extended-release tablet, Single oral dose 40mg
IS-5-MN T2	Experimental	Drug: IS-5-MN T2Isosorbide-5-mononitrate extended-release tablet, Single oral dose 40mg

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subjects should read, sign, and date an Informed Consent Form under the premise of fully understanding of this study including risks and requirements; are unable to follow the rules of this study, prior to any study procedures;
Healthy male or non-pregnant, non-lactating female of age between 18 to 50 years (both inclusive);
Body weight ≥ 50 kg for male and 45 kg for female, body mass index (BMI) within 19.0-25.0 Kg/m2;
Subject (including male subject) has no fertility plan within the future 3 months and take reliable contraceptive (physical);
Subject must agree to use an acceptable method of birth control such as sexual abstinence or barrier method of contraception from screening until 3 months after last dose of study drug;

Key exclusion criteria (21 listed)

Subject has allergic constitution or hypersensitivity to the active substance or to isosorbide dinitrate, or rare hereditary problems of galactose intolerance or fructose intolerance, the Lapp lactase deficiency, glucose - galactose malabsorption or sucrase - isomaltase insufficiency.
Subject has dysphagia or any disorder that may interfere with drug absorption, distribution, metabolism, or excretion, e.g. gastrointestinal, liver, kidney conditions.
Subject has alcoholism history or drank excessive alcohol within 6 months prior to the study (who drinking more than 21 units of alcohol per week, 1 unit = 360 mL beer (5%) = 45 mL spirit (40%) = 150 mL red-wine (12%)), positive test results for breath alcohol test at baseline, or cannot stop alcohol intake during study.
Subject smoking more than 5 cigarettes/nicotine-containing products a day within 3 months prior to screening, or refusing to abstain from smoking or consumption of tobacco products during the study.
Subject has significant change in diet or exercise habits within 3 months prior to screening.

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
IS-5-MN RAlso: ISMO Retard, IS-5-MNsingle orally dose under fed conditions on day 1 of treatment period 1 for group 1, on day 1 of treatment period 2 for group 2, on day 1 of treatment period 3 for group 3.	Drug	IS-5-MN R
IS-5-MN T1Also: IS-5-MNsingle orally dose under fed conditions on day 1 of treatment period 2 for group 1, on day 1 of treatment period 3 for group 2, on day 1 of treatment period 1 for group 3.	Drug	IS-5-MN T1
IS-5-MN T2Also: IS-5-MNsingle orally dose under fed conditions on day 1 of treatment period 3 for group 1, on day 1 of treatment period 1 for group 2, on day 1 of treatment period 2 for group 3.	Drug	IS-5-MN T2

Primary outcome

Cmax
Time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
Maximum plasma Capecitabine concentration
AUC0-t
Time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
The area under the plasma concentration time curve from zero to the last measurable concentration.
AUC0-∞
Time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
The area under the plasma concentration time curve from zero to infinity.

3 secondary outcomes

Tmax
Time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
Kel
Time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose
t½
Time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose

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 15 Jun 2018.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IS-5-MN R, IS-5-MN T1 and IS-5-MN T2 in people with Bioequivalence, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

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 6 inclusion and 21 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 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Cmax (time frame: Pre-dose and 0.5, 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 24.0 36.0 and 48.0 hr post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03557580.

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 15 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.