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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Cefadroxil from Duricef 1 gm Film Coated tablets(Smthkline Beecham Egypt,LLC affiliated co. to GalaxoSmithKline ) and Biodroxil 1 gm Film Coated tablets (Kahira Pharm &Chem .Ind. Co . for Novartis Pharma ) after a single oral dose administration of each to healthy adults under fasting conditions.
14 blood samples will be drawn in each period. The total volume of blood will not exceed 200 ml throughout the whole study. 0.00, 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours., Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVAusing 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e.
The confidence intervals of logarithmically transformed Test/Reference ratios forCmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Test | Experimental | Test drug (Duricef) 1 tablet contains 1 gm Cefadroxil |
|
| B Reference | Experimental | Reference drug (Biodroxil) 1 tablet contains 1 gm Cefadroxil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefadroxil | Drug | 1 tablet from test vs 1 tablet from reference |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal measured plasma concentration (Cmax) | Serial blood samples for determination of study drug will be collected pre-dose and at 0.00 (pre-dose), 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time of the maximum plasma concentration (tmax)measurable concentration (t) | The elimination or terminal half-life will be calculated as 0.693/ Ke | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elshafeey, Ph.D.Pharma | ahmed.elshafeey@grc-me.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genuine Research Center GRC | Cairo | Egypt |
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| Label | URL |
|---|---|
| The fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Related Topics. EURACHEM Guide, 1998 | View source |
| International conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline Q2B. Guidelines for Validation of Analytical Procedures: Methodology. November, 1996 | View source |
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| ID | Term |
|---|---|
| D002434 | Cefadroxil |
| ID | Term |
|---|---|
| D002506 | Cephalexin |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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| Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |