An Open Label Randomized, Single Dose, Two-way Crossover Bioequivalence Study to Determine the Bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.
Overview
- Phase
- Phase 1
- Intervention
- Gilenya
- Conditions
- Healthy
- Sponsor
- Genuine Research Center, Egypt
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in Healthy Human Volunteers Under Fasting Condition.
Detailed Description
Open-label, randomized, single dose, two-sequence, two-way crossover study, separated by 49 days washout interval from the first study drug administration. Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. 30 subjects will participate in the study. All dosed subject samples will be analyzed and their data will be included in the final study report. Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 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 for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
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.
- •Females should be on a suitable birth control method.
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 or nursing.
- •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
B reference
Reference drug (Gilenya) 1 capsule contains 0.5 mg Fingolimod
Intervention: Gilenya
A test
Test drug (Sphingomod ) 1 capsule contains 0.5 mg Fingolimod
Intervention: Sphingomod
Outcomes
Primary Outcomes
Cmax
Time Frame: Up to 72 hours post dose in each treatment period
Maximal measured plasma concentration
Secondary Outcomes
- Time of the maximum plasma concentration (Tmax)(Up to 72 hours post dose in each treatment period)