Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Cefadroxil From Duricef 1 gm F.C.T (GSK) and Biodroxil 1 gm F.C.T (Novartis Pharma)
Overview
- Phase
- Phase 1
- Intervention
- Cefadroxil
- Conditions
- Healthy
- Sponsor
- Genuine Research Center, Egypt
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximal measured plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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%.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female, age 18 to 55 years, inclusive.
- •Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI)
- •Medical demographics without evidence of clinically significant deviation from normal medical condition.
- •Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- •Subject does not have allergy to the drugs under investigation.
Exclusion Criteria
- •Subjects with known allergy to the products tested.
- •Subjects whose values of BMI were outside the accepted normal ranges.
- •Female subjects who were pregnant, nursing or taking birth control pills.
- •Medical demographics with evidence of clinically significant deviation from normal medical condition.
- •Results of laboratory tests which are clinically significant.
- •Acute infection within one week preceding first study drug administration.
- •History of drug or alcohol abuse.
- •Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- •Subject is on a special diet (for example subject is vegetarian).
- •Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
Arms & Interventions
A Test
Test drug (Duricef) 1 tablet contains 1 gm Cefadroxil
Intervention: Cefadroxil
B Reference
Reference drug (Biodroxil) 1 tablet contains 1 gm Cefadroxil
Intervention: Cefadroxil
Outcomes
Primary Outcomes
Maximal measured plasma concentration (Cmax)
Time Frame: 12 hours
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.
Secondary Outcomes
- Time of the maximum plasma concentration (tmax)measurable concentration (t)(12 hours)