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A Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039958
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
MinaPharm Pharmaceuticals
Information provided by (Responsible Party):
Genuine Research Center, Egypt

Brief Summary:
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir and Ledipasvir from Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA) in Healthy Human Volunteers Under Fasting Condition.

Condition or disease Intervention/treatment Phase
Healthy Drug: Soviredia Drug: Harvoni (first dose) Drug: Harvoni (Second dose) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Partial replicate crossover study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study of Sofosbuvir and Ledipasvir From Soviredia 90/400 mg Tablets (Minapharm, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)
Actual Study Start Date : April 5, 2017
Actual Primary Completion Date : May 13, 2017
Actual Study Completion Date : May 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: T test
Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Drug: Soviredia
Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Other Name: Harvoni

Active Comparator: B reference (first dose)
Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Drug: Harvoni (first dose)
Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Other Name: Harvoni

Active Comparator: B reference (second dose)
Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Drug: Harvoni (Second dose)
Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
Other Name: Harvoni




Primary Outcome Measures :
  1. Maximal measured plasma concentration (Cmax) [ Time Frame: Up to 72 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, 1.33, 1.66, 2.00, 2.50, 3.00, 4.00, 6.00, 7.00 , 9.00, 12.00, 24.00, 48.00 and 72.00 hours


Secondary Outcome Measures :
  1. Time of the maximum plasma concentration (Tmax) [ Time Frame: Up to 72 hours post dose in each treatment period ]
    The amount of time that a drug is present at the maximum concentration in serum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039958


Locations
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Egypt
Genuine Research Center GRC
Cairo, Egypt, 11757
Sponsors and Collaborators
Genuine Research Center, Egypt
MinaPharm Pharmaceuticals
Investigators
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Study Chair: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center
Additional Information:
Publications:
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Responsible Party: Genuine Research Center, Egypt
ClinicalTrials.gov Identifier: NCT04039958    
Other Study ID Numbers: GRC/1/17/635
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents