Overview

Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
Male
Summary
To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pharmaceutical Research Unit, Jordan
Collaborator:
Abdi Ibrahim Ilac San. ve Tic A.S.
Treatments:
Dirithromycin
Erythromycin
Criteria
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