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

NCT04039958 | Completed Phase 1 FDA Drug

• 1 other identifier: GRC/1/17/635
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Maximal measured plasma concentration (Cmax)

  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

  Up to 72 hours post dose in each treatment period

Secondary Outcomes (1)

• Time of the maximum plasma concentration (Tmax)

  Up to 72 hours post dose in each treatment period

Study Arms (3)

T test

EXPERIMENTAL

Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Drug: Soviredia

B reference (first dose)

ACTIVE COMPARATOR

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Drug: Harvoni (first dose)

B reference (second dose)

ACTIVE COMPARATOR

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Drug: Harvoni (Second dose)

Interventions

Soviredia DRUG

Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Also known as: Harvoni

T test

Harvoni (first dose) DRUG

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Also known as: Harvoni

B reference (first dose)

Harvoni (Second dose) DRUG

Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir

Also known as: Harvoni

B reference (second dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• MinaPharm Pharmaceuticals: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.

  PMID: 11381568 BACKGROUND

• 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.

  PMID: 2004861 BACKGROUND

• 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. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Partial replicate crossover study

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: July 31, 2019
• Study Start: April 5, 2017
• Primary Completion: May 13, 2017
• Study Completion: May 28, 2017
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

EG (1)