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| Name | Class |
|---|---|
| Abdi Ibrahim Ilac San. ve Tic A.S. | INDUSTRY |
The purpose of this study is to assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine in plasma and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.
An open-label, randomized, two-treatments, three-periods, three-sequences, semi-replicate crossover bioequivalence 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 |
|---|---|---|---|
| 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 |
|
| DYNABAC 250 MG ENTERIC COATED TABLET | Experimental | DYNABAC 250 MG ENTERIC COATED TABLET of Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey, two tablets, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIRITHROMYCIN 500 MG ENTERIC COATED TABLET | Drug |
| ||
| DYNABAC 250 MG ENTERIC COATED TABLET |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax Ratio | Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the reference variance of σw2 within subject variability for the reference for 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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| 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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| Drug |
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