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A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)

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ClinicalTrials.gov Identifier: NCT03062423
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
Al-debeiky pharma
Information provided by (Responsible Party):
Genuine Research Center, Egypt

Tracking Information
First Submitted Date  ICMJE February 16, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
Maximal measured plasma concentration (Cmax) [ Time Frame: Up to 7 hours post dose in each treatment period ]
Serial blood samples for determination of study drug will be collected at 0, 00, 0,166, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00 and 7.00 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
Time of the maximum plasma concentration (Tmax) [ Time Frame: Up to 7 hours post dose in each treatment period ]
The amount of time that a drug is present at the maximum concentration in serum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Official Title  ICMJE Comparative Open-label,Randomized, Fed, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Brief Summary Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier 400 mg F.C.T (Al-debeiky pharma, Egypt) versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Detailed Description

Primary Pharmacokinetic Parameters: Cmax, Area under cover (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Sofodelevier
    1 tablet contains 400 mg sofosbuvir
    Other Name: Sovaldi
  • Drug: Sovaldi (fist dose)
    1 tablet contains 400 mg sofosbuvir
    Other Name: Sovaldi
  • Drug: Sovaldi (second dose)
    1 tablet contains 400 mg sofosbuvir
    Other Name: Sovaldi
Study Arms  ICMJE
  • Experimental: T test
    Test drug (Sofodelevier)1 tablet contains 400 mg Sofosbuvir
    Intervention: Drug: Sofodelevier
  • Active Comparator: B reference (first dose)
    Reference drug (Sovaldi)1 tablet contains 400 mg Sofosbuvir
    Intervention: Drug: Sovaldi (fist dose)
  • Active Comparator: B reference (second dose)
    Reference drug (Sovaldi)1 tablet contains 400 mg Sofosbuvir
    Intervention: Drug: Sovaldi (second dose)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2017)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03062423
Other Study ID Numbers  ICMJE GRC/1/16/605
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Genuine Research Center, Egypt
Study Sponsor  ICMJE Genuine Research Center, Egypt
Collaborators  ICMJE Al-debeiky pharma
Investigators  ICMJE
Study Director: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center
PRS Account Genuine Research Center, Egypt
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP