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

Overview

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.

Full Title of Study: “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 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 Fasting Conditions.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Detailed Description

An open-label, randomized, two-treatments, two-periods, two-sequences, crossover bioequivalence pilot 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).

Interventions

  • Drug: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
  • Drug: DYNABAC 250 MG ENTERIC COATED TABLET

Arms, Groups and Cohorts

  • Experimental: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
    • DIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey one tablet, once
  • Active Comparator: DYNABAC 250 MG ENTERIC COATED TABLET
    • DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pharmaceutical Research Unit, Jordan
  • Collaborator
    • Abdi Ibrahim Ilac San. ve Tic A.S.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rana T Bustami, Phd.pharmacy, Principal Investigator, PRU

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