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HealthyPhase 1NCT02237807

Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions

A Phase 1 study testing DIRITHROMYCIN 500 MG ENTERIC COATED TABLET and DYNABAC 250 MG ENTERIC COATED TABLET in people with Healthy, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.

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 study is to assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine in plasma and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence… Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
DIRITHROMYCIN 500 MG ENTERIC COATED TABLET and DYNABAC 250 MG ENTERIC COATED TABLET
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteJordan
Study dates
Sep 2014to Oct 2014
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects.
  • Ethnic Group: Arab \& Mediterranean.
  • Race: Mixed skin (white \& black skin people).
  • Age 18-50 years.
  • Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
  • Subject is available for the whole study period and gave written informed consent.
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  • Normal Physical examination.
  • Vital signs within normal ranges.
  • All laboratory screening results within the normal range, or being assessed as clinically Non-significant by the attending physician.
  • Normal Kidney \& Liver functions test

Who cannot join

  • Women of childbearing potential who don't use any contraceptive method, pregnant and/or lactating women.
  • Ethnic Group (Non- Arab \&/ or Non- Mediterranean)
  • History of severe allergy or allergic reactions to study drug or related drugs or heparin
  • Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • History of serious illness that can impact fate of drugs
  • Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease.
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  • Clinically significant illness 4 weeks before study Period I
  • Mental disease.
  • Smoking of more than 10 cigarettes per day
  • The intake of alcohol and grapefruit during the study.
  • The intake of caffeine, xanthenes, or CO2-containing beverages during hospitalization.
  • Regular use of medication.
  • Having taken medication that could affect the investigated drug product: a) Regular consumption of drugs during the two weeks prior to study initiation day, b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine and methadone) during one month before the study initiation.
  • Presence of any significant physical or organ abnormality
  • Donation of 1) at least 400 ml of blood within 60 days, or 2) more than 150 ml of blood within 30 days, or 3) more than 100 ml blood plasma or platelets within 14 days before study Period I
  • Participation in another bioequivalence study and/or Clinical trials within 80 days prior to the start of this study Period I
  • Following a special diet (e.g. vegetarian) or dieting one month before the study initiation.
  • Subjects with seizures or prior history of seizures.
  • Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide antibiotics
  • Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
  • Consumption of grapefruit or grapefruit containing products within 7 days of drug administration
  • Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
  • Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
  • Subjects with history of Liver disease.
  • Abnormal Vital Signs.
  • Abnormal Kidney and/or Liver functions test.
  • Vomiting, Diarrhea on admission

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit

    Amman, 11941

Other trials in Jordan

About this study

Official title: Comparative, Randomized, Three -Period, Two-treatment, Three -Sequence, Open Label, Semi-replicate Crossover Bioequivalence Study of Dirithromycin 500 mg Enteric Coated Tablet (One Tablet) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) Versus Dynabac 250 mg Enteric Coated Tablet (Two Tablets) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fed Conditions

The purpose of this study is to assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine in plasma and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.

Read the detailed description

An open-label, randomized, two-treatments, three-periods, three-sequences, semi-replicate crossover bioequivalence study with a washout period of at least 14 days between doses. Healthy, mixed skin Arab \& Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of not more than 10 cigarettes per day).

Conditions
Healthy
Being tested
DIRITHROMYCIN 500 MG ENTERIC COATED TABLET, DYNABAC 250 MG ENTERIC COATED TABLET
Keywords
Fed Conditions

What participants receive

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

  • DIRITHROMYCIN 500 MG ENTERIC COATED TABLETDrug

  • DYNABAC 250 MG ENTERIC COATED TABLETDrug

Study groups in NCT02237807
Study groupRoleWhat they receive
DIRITHROMYCIN 500 MG ENTERIC COATED TABLETExperimentalDIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey one tablet, once
Receives: Drug: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
DYNABAC 250 MG ENTERIC COATED TABLETExperimentalDYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once
Receives: Drug: DYNABAC 250 MG ENTERIC COATED TABLET

What is being measured

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

  1. Cmax Ratio

    Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the reference variance of σw2 within subject variability for the reference for Erythromycylamine.

    Measured: pre-dosing and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing.

  2. AUC Ratio

    The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00%based on Erythromycylamine

    Measured: pre-dosing and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing

Timeline

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

  1. First posted11 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2014
  4. Study completionOct 2014

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237807
Sponsor's protocol ID
DIRI521/PRO-00
Status last verified
Sep 2020
First submitted
9 Sep 2014
Last updated
18 Sep 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DIRITHROMYCIN 500 MG ENTERIC COATED TABLET and DYNABAC 250 MG ENTERIC COATED TABLET in people with Healthy, run by Pharmaceutical Research Unit, Jordan at 1 site in Jordan.

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 10 inclusion and 27 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 18 Sep 2020. 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 Jordan. 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 Ratio (time frame: pre-dosing and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00 hours after dosing.). 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 NCT02237807.

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 18 Sep 2020.

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