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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02237807
• Date of registration: 09/09/2014
• Prospective Registration: No
• Primary sponsor: Pharmaceutical Research Unit, Jordan
• Public title: Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions
• Scientific 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 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 Fed Conditions
• Date of first enrolment: September 2014
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02237807
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Jordan

Contacts

• Name: Rana T Bustami, Phd.pharmacy
• Affiliation: PRU

Key inclusion & exclusion 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. The intake of alcohol and grapefruit during the study.

11. The intake of caffeine, xanthenes, or CO2-containing beverages during hospitalization.

12. Regular use of medication.

13. 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.

14. Presence of any significant physical or organ abnormality

15. 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

16. Participation in another bioequivalence study and/or Clinical trials within 80 days
prior to the start of this study Period I

17. Following a special diet (e.g. vegetarian) or dieting one month before the study
initiation.

18. Subjects with seizures or prior history of seizures.

19. Prior history of hypersensitivity to dirithromycin, erythromycin, or other macrolide
antibiotics

20. Any significant clinical abnormality including HBsAg, HCV, and / or HIV.

21. Consumption of grapefruit or grapefruit containing products within 7 days of drug
administration

22. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose
of the study medication.

23. Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent
significant change in dietary or exercise habits.

24. Subjects with history of Liver disease.

25. Abnormal Vital Signs.

26. Abnormal Kidney and/or Liver functions test.

27. Vomiting, Diarrhea on admission



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: DIRITHROMYCIN 500 MG ENTERIC COATED TABLET

Drug: DYNABAC 250 MG ENTERIC COATED TABLET

Primary Outcome(s)

AUC 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]

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.]

Secondary ID(s)

DIRI521/PRO-00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abdi Ibrahim Ilac San. ve Tic A.S.