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)

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

Tracking Information

• First Submitted Date: February 16, 2017
• First Posted Date: February 23, 2017
• Last Update Posted Date: August 1, 2019
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Healthy

Intervention

• 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

• 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 *

• Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. Erratum in: J Pharmacokinet Pharmacodyn. 2002 Feb;29(1):101..
• Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 20, 2017): 36
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03062423
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Genuine Research Center, Egypt
• Study Sponsor: Genuine Research Center, Egypt
• Collaborators: Al-debeiky pharma

Investigators

• Study Director: Ahmed Elshafeey, Ph.D. Pharma; Genuine Research Center

• PRS Account: Genuine Research Center, Egypt
• Verification Date: July 2019