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Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)

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ClinicalTrials.gov Identifier: NCT02675127
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
European Egyptian Pharmaceutical Industries
Information provided by (Responsible Party):
Genuine Research Center, Egypt

Brief Summary:
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition

Condition or disease Intervention/treatment Phase
Healthy Drug: Daktavira Drug: Daklinza Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition.
Study Start Date : December 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arm Intervention/treatment
Experimental: A Test
Test drug (Daktavira, European Egyptian Pharmaceutical Industries)1 tablet contains 60 mg Daclatasvir
Drug: Daktavira
1 tablet contains 60 mg Daclatasvir
Other Name: Daklinza

Active Comparator: B Reference
Reference drug (Daklinza, (Bristol-Myers Squibb Pharma, UK)) 1 tablet contains 60 mg Daclatasvir
Drug: Daklinza
1 tablet contains 60 mg Daclatasvir




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, 0.50, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 3.50, 4.00, 6.00, 8.00, 12.00, 16.00, 24.00, 48.00, 72.00 hrs


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): NCT02675127


Locations
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Egypt
Genuine Research Center GRC
Cairo, Egypt, 11757
Sponsors and Collaborators
Genuine Research Center, Egypt
European Egyptian Pharmaceutical Industries
Investigators
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Study Director: Ahmed Elshafeey, Ph.D. Pharma Genuine Research Center
Additional Information:
Publications:
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Responsible Party: Genuine Research Center, Egypt
ClinicalTrials.gov Identifier: NCT02675127    
Other Study ID Numbers: GRC/1/15/588
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided