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Human Bioequivalence Trial of Sofosbuvir Tablets

Human Bioequivalence Trial of Sofosbuvir Tablets

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016633
Enrollment
Unknown
Registered
2018-06-14
Start date
2018-06-01
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C

Interventions

Test preparation and fasting group:Fasting test preparations Sofosbuvir tablets(1dose, 400 mg)
Reference preparation and fasting group:Fasting to Reference Preparation Sofosbuvir (1 dose, 400 mg)
Test preparation and fed group:Postprandial test preparation of sofbuvir tablets (1 dose, 400mg)
Reference preparation and fed group:Postprandial reference preparation of soflobuvir(1 dose, 400 mg)

Sponsors

The Third Hospital of Changsha
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy subjects over the age of 18 years men and women.

Exclusion criteria

Exclusion criteria: 1. Have heart, liver, kidney, digestive tract, endocrine, blood system, respiratory system, nervous system and mental disorders and metabolic disorders and other medical history, or have a history of cancer; 2. Results of physical examination, electrocardiogram, laboratory projects and tests related to the study are abnormal and of clinical significance; 3. Had any surgery within three months before the screening; 4. A history of drug abuse during the past five years or those who used drugs within the first three months of screening; 5. Alcohol abuse history or moderate alcohol consumption in the past 2 years; 6. Take any prescription, over-the-counter, any vitamin product, nutraceutical, or herbal medicine within 14 days prior to taking the study medication; 7. Have taken any food or drink containing caffeine or xanthine, such as coffee, tea, chocolate, cola, etc. within 48 hours prior to taking the study medication.

Design outcomes

Primary

MeasureTime frame
Cmax;AUC;

Countries

China

Contacts

Public ContactXin Li

Third Hospital of Changsha

920365846@qq.com+86 0731-85171383

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026