Bioequivalence Study of Daclatasvir From Daclatasvir Zeta 60 mg Film Coated Tablets (Zeta Pharm Pharmaceutical Industries, Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)

G

Genuine Research Center

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Clatazev
Drug: Daclatasvir Zeta

Study type

Interventional

Funder types

Industry

Identifiers

NCT02756936
GRC/1/16/600

Details and patient eligibility

About

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Daclatasvir zeta 60 mg F.C.T ( Zeta Pharm Pharmaceutical Industries, Egypt) versus Clatazev 60 mg F.C.T (Bristol-Myers Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male or female, age 18 to 55 years, inclusive.
  • Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
  • Medical demographics without evidence of clinically significant deviation from normal medical condition.
  • Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
  • Subject does not have allergy to the drugs under investigation.

Exclusion criteria

  • Subjects with known allergy to the products tested.
  • Subjects whose values of BMI were outside the accepted normal ranges.
  • Female subjects who were pregnant, nursing or taking birth control pills.
  • Medical demographics with evidence of clinically significant deviation from normal medical condition.
  • Results of laboratory tests which are clinically significant.
  • Acute infection within one week preceding first study drug administration.
  • History of drug or alcohol abuse.
  • 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.
  • Subject is on a special diet (for example subject is vegetarian).
  • 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.
  • 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.
  • Subject has a history of severe diseases which have direct impact on the study.
  • Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
  • Subject intends to be hospitalized within 3 months after first study drug administration.
  • 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

A Test
Experimental group
Description:
Test drug (Daclatasvir zeta)1 tablet contains 60 mg Daclatasvir
Treatment:
Drug: Daclatasvir Zeta
B Reference
Active Comparator group
Description:
Reference drug (Clatazev)) 1 tablet contains 60 mg Daclatasvir
Treatment:
Drug: Clatazev

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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