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A study to compare the relative bioavailability of SMTD and Gilead formulations of ledipasvir/sofosbuvir 90/400 mg tablets in 24 healthy adult male volunteers under fasting conditions

Protocol summary

Summary
This randomized, single-dose, two-way, crossover study is conducted to compare the relative bioavailability of two formulations of ledipasvir/sofosbuvir tablets under fasting conditions in 24 healthy adults male volunteers. In each study period, a single 90/400 mg dose is administered to the subjects following an overnight fast of at least 10 hours. The test formulation is ledipasvir/sofosbuvir 90/400 mg tablets manufactured by Sobhan Medicine Trade Development (SMTD) Company and the reference formulation is HARVONI® (ledipasvir/sofosbuvir) 90/400 mg tablet manufactured by Gilead. The subjects will receive the test products and the reference product in two periods; the order of administration will be according to the dosing randomization schedule. There will be a 7-day interval between treatments. Venous blood (3 ml) for the determination of ledipasvir (LP), sofosbuvir (SF) and the metabolite of SF in plasma is sampled before dosing and at 0.25, 0.5, 0.7, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 48, and 72 hours after dosing (a total of 17 samples per profile). Criteria for the evaluation include the time course of the plasma concentrations of LP, SF and SF metabolite over the 72 h after the administration of the products as summarized by the area under the curve from time zero to infinity (AUC0-inf), the maximum plasma concentration (Cmax), time to reach Cmax (Tmax) and plasma half-life (t1/2). Statistical analysis is performed to evaluate the relative bioavailability of the test formulation to that of the reference product.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017022213776N4
Registration date: 2017-03-07, 1395/12/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-07, 1395/12/17
Registrant information
Name
Hossein Amini
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
hamini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Sobhan Medicine Trade Development Company
Expected recruitment start date
2017-04-01, 1396/01/12
Expected recruitment end date
2017-10-01, 1396/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study to compare the relative bioavailability of SMTD and Gilead formulations of ledipasvir/sofosbuvir 90/400 mg tablets in 24 healthy adult male volunteers under fasting conditions
Public title
Bioequivalence study of ledipasvir/sofosbuvir 90/400 mg tablets under fasting conditions
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or sensitivity to ledipasvir/sofosbuvir, or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. Presence of a medical condition requiring regular treatment with prescription drugs. 5. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. 6. Receipt of any drug as part of a research study within 30 days prior to dosing. 7. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing.
Age
From 18 years old to 50 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Km 2 Sari Road Gorgan
City
Gorgan
Postal code
Approval date
2017-01-15, 1395/10/26
Ethics committee reference number
ir.goums.rec.1395.229

Health conditions studied

1

Description of health condition studied
Healthy volunteers
ICD-10 code
Y41.5
ICD-10 code description
Antiviral drugs

Primary outcomes

1

Description
Maximum plasma concentration (Cmax)
Timepoint
After intervention
Method of measurement
Blood sampling

2

Description
Area-under the curve (AUC) for plasma concentrations
Timepoint
After intervention
Method of measurement
Blood sampling

Secondary outcomes

1

Description
Time to reach Cmax (Tmax)
Timepoint
After intervention
Method of measurement
Blood sampling

Intervention groups

1

Description
Single dose ofone ledipasvir/sofosbuvir 90/400 mg tablets manufactured by Sobhan Medicine Trade Development Company
Category
Treatment - Drugs

2

Description
Single dose of one Harvoni (ledipasvir/sofosbuvir) 90/400 mg tablets manufactured by Gilead
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis Center
Full name of responsible person
Mr. Ghezelsefloo
Street address
Taleghani Street, Shaheed Motahhari Hospital
City
Gonbad-Kavous

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sobhan Medicine Trade Development Company
Full name of responsible person
Mrs. Parhoon
Street address
Central Office, Yosef Abad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sobhan Medicine Trade Development Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan Bioanalysis Center
Full name of responsible person
Dr. Hossein Amini
Position
Head of Center
Other areas of specialty/work
Street address
Golshahr Bolv., Golshahr 14, Aftabgardan Bulding, No. 6
City
Gorgan
Postal code
Phone
+98 21 3252 5972
Fax
Email
haminhplc@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Hossein Amini
Position
Associtate Professor, Ph.D
Other areas of specialty/work
Street address
University Main Campus
City
Gorgan
Postal code
Phone
+98 17 3252 5972
Fax
Email
haminhplc@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Hossein Amini
Position
Associtate Professor, Ph.D
Other areas of specialty/work
Street address
University Main Campus
City
Gorgan
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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