Comparative Randomized, Single Dose, Two-Way Crossover, Open-Label Study to Determine the Bioequivalence of Sofosbuvir 400 mg Tablets Formulations, Sovaldi and HEPASOF (400 mg), after Oral Administration to Healthy Thai Volunteers under Fasting Con

The Government Pharmaceutical Organization0 sites82 target enrollmentJune 22, 2017

ConditionsHealthy male and female volunteers

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy male and female volunteers
Sponsor: The Government Pharmaceutical Organization
Enrollment: 82
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 22, 2017

End Date

August 30, 2017

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

The Government Pharmaceutical Organization

Eligibility Criteria

Inclusion Criteria

•a)Be healthy male or female subjects between 18\-55 years of age (both inclusive).
•b)Have a Body Mass Index (BMI) between 18\.0\-25\.0 (both inclusive), calculated as weight in kg/height in m2\.
•c)Have no evidence of underlying disease or clinically significant abnormal finding during screening, medical history examination, physical examination.
•d)Have no abnormal finding during laboratory examination such as complete blood count, hematocrit, hemoglobin, fasting blood sugar, blood urea nitrogen (BUN), serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, total protein, albumin, HBsAg, Anti\-HCV, Anti\-HIV, urine analysis, chest X\-ray and 12\-Lead ECG recording or judged by physician as clinically insignificant or acceptable.
•e)Able to understand and comply with the study procedures, in the opinion of the Principal Investigator.
•f)Able to give voluntary written inform consent for participation in the trial.
•g)In case of female subjects:
•â€¢Females of child\-bearing potential agree to use an acceptable method of birth control for entire duration of the study as judge by the investigator(s):
•i.Non hormonal intrauterine device in place of at least 3 months prior to the start of the study and remaining in place during the study period, or
•ii.Barrier methods containing or used in conjunction with a spermicidal agent, such as condoms, foams, jellies, diaphragm, etc., or

Exclusion Criteria

•a)Any history of hypersensitivity to sofosbuvir or any of its excipients.
•b)A recent history or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
•c)Clinically significant illness within 4 weeks before the start of the study.
•d)Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication.
•e)A positive hepatitis screen including HBsAg and/or anti\-HCV.
•f)A positive test result for anti\-HIV.
•g)Has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood (1 unit or 350 mL) in the preceding 90 days prior to the start of the study.
•h)History of difficulty with donating blood or difficulty in accessibility of veins.
•i)A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hours prior to dosing, or testing positive in pre\-study breath test for alcohol consumption.
•j)Consumption of grapefruit, pomelo, orange, or any products containing these fruits within 48 hours prior to dosing.