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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 November 2015 |
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Main ID: |
NCT02605798 |
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Date of registration:
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12/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)
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Scientific title:
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Comparative Open-label,Randomized, Fasting, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom) |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02605798 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed Elshafeey, Ph.D. Pharma |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genuine Research Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Healthy male or female, age 18 to 55 years, inclusive.
2. Body weight within 15% of normal range according to the accepted normal values for
body mass index (BMI).
3. Medical demographics without evidence of clinically significant deviation from normal
medical condition.
4. Results of clinical laboratory test are within the normal range or with a deviation
that is not considered clinically significant by principal investigator.
5. Subject does not have allergy to the drugs under investigation.
Exclusion Criteria:
1. Subjects with known allergy to the products tested.
2. Subjects whose values of BMI were outside the accepted normal ranges.
3. Female subjects who were pregnant, nursing or taking birth control pills.
4. Medical demographics with evidence of clinically significant deviation from normal
medical condition.
5. Results of laboratory tests which are clinically significant.
6. Acute infection within one week preceding first study drug administration.
7. History of drug or alcohol abuse.
8. 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.
9. Subject is on a special diet (for example subject is vegetarian).
10. 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.
11. Subject does not agree not to consume any beverages or foods containing grapefruit 7
days prior to first study drug administration until the end of the study.
12. Subject has a history of severe diseases which have direct impact on the study.
13. Participation in a bioequivalence study or in a clinical study within the last 6
weeks before first study drug administration.
14. Subject intends to be hospitalized within 3 months after first study drug
administration.
15. Subjects who, through completion of this study, would have donated more than 500 ml
of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120
days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Sovaldi
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Drug: Elbanovir
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Primary Outcome(s)
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Maximal measured plasma concentration (Cmax)
[Time Frame: Up to 7 hours post dose in each treatment period]
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Secondary Outcome(s)
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Time of the maximum plasma concentration (Tmax)
[Time Frame: Up to 7 hours post dose in each treatment period]
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Secondary ID(s)
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GRC/1/15/567
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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