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HealthyPhase 1NCT02101710

Pharmacokinetic Properties of Isosorbide-5-mononitrate Under Fasting and Fed Condition in Healthy Male Subjects

A Phase 1 study testing Elantan SR 60 mg and Imdur SR 60 mg in people with Healthy, run by UCB Korea Co., Ltd. at 1 site in South Korea.

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

This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects. Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Elantan SR 60 mg and Imdur SR 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
Jun 2011to Jul 2011
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 19 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the subject
  • Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete the schedule of study assessment), visit schedule or medication intake according to the judgment of the investigator
  • Subject is healthy Korean male, 19-55 years of age
  • Subject is of normal body weight as determined by a body mass index between 18.5 kg/m^2 and 24.9 kg/m^2
  • Sitting blood pressure within the following range: SBP (Systolic Blood Pressure), 90-139 mmHg; DBP (Diastolic Blood Pressure ), 50-89 mmHg
  • Subject has no abnormal symptom in a physical examination without congenital or chronic disease

Who cannot join

  • Subject has previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study
  • Subject has participated in another study of an investigational medication (or a medical device) within the last 90 days or is currently participating in another study of an investigational medication (or a medical device)
  • Subject has a history of chronic alcohol or drug abuse within the last 6 months
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
  • Subject has a known hypersensitivity to nitrate or to any components of the investigational medicinal product or reference drugs as stated in this protocol
  • Subject has the history or present condition of cardiovascular diseases, like acute circulatory failure (shock, vascular collapse), very low BP, acute myocardial infarction with low filling pressures, arrhythmia, left heart failure with low filling pressures, hypotension, acute attacks of angina, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, cardiac tamponade, aortic valve and/or mitral valve stenosis
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  • Subject has the history or present condition of severe anemia, head trauma, cerebral haemorrhage, hematopenia, severe cerebrovascular insufficiency, glaucoma, gastrointestinal disorder, neurological abnormalities, hepatic disorder, renal, pulmonary or metabolic diseases
  • Subject use a phosphodiesterase 5 inhibitor (sildenafil, tadalafil and vardenafil)
  • Symptomatic or asymptomatic orthostatic hypotension at screening defined as a 20 mmHg or more decrease in systolic pressure, or 10 mmHg or more decrease in diastolic pressure after 1 and 3 minutes standing with the arm relaxed at the side (time zero begins after the subject is upright). 5 minutes of supine rest is used as baseline
  • Subject has the family or personal history of abnormal bleeding
  • Subject had clinically relevant out of range values for hematology and clinical chemistry parameters. However, in agreement with the sponsor, the Investigator may include a subject having values outside the accepted range if, in his/her opinion, these values are of no clinical significance and justification is given
  • Subject had any clinically relevant abnormality in physical examination
  • Subject has made a blood donation or had a comparable blood loss (>400ml) within the last 3 months prior to the first day of dosing
  • Any clinical conditions that in the opinion of the Investigator would make the subject unsuitable for the study
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption due to the presence of lactose
  • Subjects who have taken drug products that are enzyme inducers, such as barbiturates, or inhibitors; or who drank excessive alcohol within one month prior to the initiation of the BE (Bioequivalence) study
  • Subjects who have taken drug products that could influence the results of the BE study within 10 days before the initiation of the BE study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • 1

    Jeollabuk-do

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, One Dose, 2-way Crossover Study to Evaluate the Bioequivalence of Elantan SR* 60 mg in Comparison With Imdur SR* 60 mg Under Fasted and Fed Conditions in Healthy Korean Male Subjects (*Sustained Release)

This study it to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects.

Read the detailed description

This study is to evaluate the bioequivalence of Elantan SR 60 mg compared to Imdur SR 60 mg in sixty healthy Korean male subjects. Thirty subjects will be participating in a fasted state and other thirty subjects will be in a fed state. Elantan SR 60 mg and Imdur 60 mg are two formulations of Isosorbide 5-mononitrate.

Conditions
Healthy
Being tested
Elantan SR 60 mg, Imdur SR 60 mg
Keywords
Bioequivalence, Isosorbide 5-mononitrate, Elantan, Imdur, Korean, Healthy

What participants receive

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

  • Elantan SR 60 mgDrug

    Also called Isosorbide 5-mononitrate

    • Trade Name: Elantan
    • Active Substance: Isosorbide 5-mononitrate
    • Pharmaceutical form: Tablet
    • Concentration: 60 mg
    • Route of Administration: Oral administration

  • Imdur SR 60 mgDrug

    Also called Isosorbide 5-mononitrate

    • Trade Name: Elantan
    • Active Substance: Isosorbide 5-mononitrate
    • Pharmaceutical form: Tablet
    • Concentration: 60 mg
    • Route of Administration: Oral administration
Study groups in NCT02101710
Study groupRoleWhat they receive
Elantan SR 60 mg fedExperimentalElantan SR 60 mg is orally administered on Day 1 of treatment period 1 for Fed group 2 and on Day 1 of treatment period 2 for Fed group 1.
Receives: Drug: Elantan SR 60 mg
Imdur SR 60 mg fedExperimentalImdur SR 60 mg is orally administered on Day 1 of treatment period 1 for Fed group 1 and on Day 1 of treatment period 2 for Fed group 2.
Receives: Drug: Imdur SR 60 mg
Elantan SR 60 mg fastedExperimentalElantan SR 60 mg is orally administered on Day 1 of treatment period 1 for Fasted group 2 and on Day 1 of treatment period 2 for Fasted group 1.
Receives: Drug: Elantan SR 60 mg
Imdur SR 60 mg fastedExperimentalImdur SR 60 mg is orally administered on Day 1 of treatment period 1 for Fasted group 1 and on Day 1 of treatment period 2 for Fasted group 2.
Receives: Drug: Imdur SR 60 mg

What is being measured

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

  1. Area Under the Concentration-time Curve vs. time curve observed from time Baseline to the Last Quantifiable point (AUC(0-t))

    Measured: Samples will be taken predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  2. Maximum Observed Plasma Concentration (Cmax)

    Measured: Samples will be taken predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

Secondary outcomes (8)

  1. Area under the plasma concentration-time curve from zero up to infinity (AUC(0-inf))

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  2. Time to reach a maximum plasma concentration (tmax)

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  3. Terminal half-life (t1/2)

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  4. Rate constant of elimination (λz)

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  5. Apparent total body clearance (CL/f)

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  6. Apparent volume of distribution (Vz/F)

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  7. AUC % extrapolation

    Measured: Samples will be taken 0 (predose) and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose

  8. Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) from the Day 1 of the first treatment period until Safety Follow Up visit

    Measured: From the Day 1 of the first treatment period until Safety Follow Up visit (Day 8)

Timeline

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

  1. First posted2 Apr 2014 (estimated)
  2. Study startJun 2011
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02101710
Sponsor's protocol ID
HD0001
Status last verified
Apr 2014
First submitted
28 Mar 2014
Last updated
17 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Jin C, Jeon JY, Im YJ, Jeong JA, Kim Y, Chae SW, Bentz J, Kumke T, Kim MG. Pharmacokinetic properties of isosorbide-5-mononitrate under fasting and fed conditions in healthy male subjects. Int J Clin Pharmacol Ther. 2015 Jan;53(1):97-106. doi: 10.5414/CP202169.

    PubMed 25492848

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elantan SR 60 mg and Imdur SR 60 mg in people with Healthy, run by UCB Korea Co., Ltd. at 1 site in South Korea.

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 17 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 Apr 2014. 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 South Korea. 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?

Area Under the Concentration-time Curve vs. time curve observed from time Baseline to the Last Quantifiable point (AUC(0-t)) (time frame: Samples will be taken predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 36 hr post-dose). The study lists 2 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 NCT02101710, which also lists 1 linked publication.

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 Apr 2014.

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