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| Name | Class |
|---|---|
| Abdi Ibrahim Ilac San. ve Tic A.S. | INDUSTRY |
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DYNABAC 250 MG ENTERIC COATED TABLET | Active Comparator | DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once |
|
| DIRITHROMYCIN 500 MG ENTERIC COATED TABLET | Experimental | DIRITHROMYCIN 500 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San.Ve Tic. A. Ş., Turkey, one tablet, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DYNABAC 250 MG ENTERIC COATED TABLET | Drug |
| ||
| DIRITHROMYCIN 500 MG ENTERIC COATED TABLET |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax Ratio | The 90% confidence interval for this measure lies within an acceptance range of 80.00%-125.00% based on Erythromycylamine. | 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. |
| AUC Ratio | The 90% confidence interval for this measure lies within an acceptance range of 80.00%-125.00%based on Erythromycylamine | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rana T Bustami, Phd.pharmacy | PRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arab Pharmaceutical industry Consulting/ Pharmaceutical Research Unit | Amman | 11941 | Jordan |
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| Drug |
|
| ID | Term |
|---|---|
| C053853 | dirithromycin |
| D013608 | Tablets, Enteric-Coated |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013607 | Tablets |
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