Bioequivalence of Entecavir Tablets (Fasting) in the Human Body

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-17010480

Enrollment

Unknown

Registered

2017-01-19

Start date

2017-01-23

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Pharmacokinetics and Bioequivalence Study in human

Interventions

1:Phase 1: Entecavir Tab 1 mg(Synco (H.K.) Limited, Hong Kong)

Phase 2: Entecavir Tab 1 mg (Bristol Myers Squibb Company, USA)

2:Phase 1: Entecavir Tab 1 mg (Bristol Myers Squibb Company, USA)

Phase 2: Entecavir Tab 1 mg(Synco (H.K.) Limited, Hong Kong)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and female aged more than 18 years; 2. Male subjects weight greater than 50 kg, the female subjects weight greater than 45 kg, BMI 19 to 26; 3. All subjects are voluntary to take part in the trial and signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Abnormalities in general physical examination or laboratory tests; 2. History of cardiovascular, haematological, hepatic, renal, biliary, gastrointestinal, psychological other acute diseases; 3. drug allergies and drug dependence; 4. AIDS and HIV positive; 5. Drug abusers; 6. Subjects in any clinical drug study within months before the study; 7. Smokers or alcohol consumers; 8. Treatment of other drugs within two weeks before the start of the study.

Design outcomes

Primary

Measure	Time frame
plasma concentration of Entecavir;	—

Countries

China

Contacts

Public ContactZhang Bikui

Institute of Clinical Pharmacy, Central South University

bikui-zh@126.com+86 13973116871

Outcome results

None listed

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