Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02185833 |
Date of registration:
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06/07/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Bioequivalence Pilot Study of Dirithromycin of (Abdi Ibrahim Ilaç San.Ve.Tic.A.S,Turkey) in Healthy Subjects Under Fasting Condition
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Scientific title:
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Comparative, Randomized, Two -Period, Two-treatment, Two -Sequence, Open Label, Crossover Bioequivalence Pilot Study of Dirithromycin 500 mg Enteric Coated Tablet (One Tablet) of (Abdi Ibrahim Ilaç San. Ve Tic. A. S., Turkey) Versus Dynabac 250 mg Enteric Coated Tablet (Two Tablets) of (Abdi Ibrahim Ilaç San. Ve Tic. A. S., Turkey) in Healthy Subjects Under Fasting Conditions. |
Date of first enrolment:
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June 2014 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02185833 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Rana T Bustami, Phd.pharmacy |
Address:
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Telephone:
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Email:
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Affiliation:
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PRU |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Healthy subjects.
2. Ethnic Group: Arab & Mediterranean.
3. Race: Mixed skin (white & black skin people).
4. Age 18-50 years.
5. Body-mass index 18.5 to 30.0 kg/m2 inclusive. (minimum of 50 kg weight)
6. Subject is available for the whole study period and gave written informed consent.
7. Normal Physical examination.
8. Vital signs within normal ranges.
9. All laboratory screening results within the normal range, or being assessed as
clinically Non-significant by the attending physician.
10. Normal Kidney & Liver functions test
Exclusion Criteria:
1. Women of childbearing potential who don't use any contraceptive method, pregnant
and/or lactating women.
2. Ethnic Group (Non- Arab &/ or Non- Mediterranean)
3. History of severe allergy or allergic reactions to study drug or related drugs or
heparin
4. Known history or presence of food allergies, or any condition known to interfere
with the absorption, distribution, metabolism or excretion of drugs
5. History of serious illness that can impact fate of drugs
6. Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine,
musculoskeletal, neurological, hematological, liver or kidney disease.
7. Clinically significant illness 4 weeks before study Period I
8. Mental disease.
9. Smoking of more than 10 cigarettes per day
10. Intake of Alcohol, caffeine, or xanthine beverages 16 hrs before each study drug
administration.
11. Regular use of medication.
12. 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.
13. Presence of any significant physical or organ abnormality
14. 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
15. Participation in another bioequivalence study and/or Clinical trials within 80 days
prior to the start of this study Period I
16. Following a special diet (e.g. vegetarian) or dieting one month before the study
initiation.
17. Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide
antibiotics
18. Subjects with seizures or prior history of seizures
19. Any significant clinical abnormality including HBsAg, HCV, and / or HIV.
20. Consumption of grapefruit or grapefruit containing products within 7 days of drug
administration
21. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose
of the study medication.
22. Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent
significant change in dietary or exercise habits.
23. Abnormal Vital Signs.
24. Abnormal Kidney and/or Liver functions test.
25. Vomiting, Diarrhea on admission
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
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Drug: DYNABAC 250 MG ENTERIC COATED TABLET
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Primary Outcome(s)
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AUC Ratio
[Time Frame: pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing]
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Cmax Ratio
[Time Frame: pre-dosing and at 1.00, 1.50, 2.00, 2.25, 2.50, 2.75 ,3.00 ,3.25, 3.50 ,3.75 ,4.00 ,4.50 ,5.00 ,5.50 ,6.00 ,8.00, 10.00, 12.00, 14.00, 16.00, 24.00, 36.00, 48.00, 72.00, 96.00 and 120.00hours after dosing]
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Secondary ID(s)
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DIRI502/PRO-00
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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