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Bioequivalence of Lamivudine to healthy Chinese volunteers in a single-dose study

Bioequivalence of Lamivudine to healthy Chinese volunteers in a single-dose study

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008249
Enrollment
Unknown
Registered
2016-04-08
Start date
2016-03-29
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

Chronic hepatitis B

Interventions

Group A fasting:Group A fasting T-R
Group B fasting:Group B fasting R-T
Group A after the meal:Group A after the meal T-R
Group B after the meal:Group B after the meal R-T

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Chinese healthy subjects, gender parity; 2. Aged 18 to 50 years old (including the age of 18 and 50); 3. Should be not less than 50 kg weight, body mass index (BMI) 19-28 kg/m2 / BMI = weight/height 2 (including 19 and 28 kg/m2); 4. Health in good condition, not intentional, liver, kidney, gastrointestinal tract, nervous system and history of mental disorder and metabolic abnormalities; 5. Have the ability to communicate with staff normal and in accordance with relevant regulations of the hospital 6. To be able to communicate with the smooth, understand and comply with the study requirements; 7. Voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The physical examination, vital signs, abnormal electrocardiogram (ecg) and laboratory examination (to judge by the clinicians have clinical significance); 2. Always have the digestive system disease or a history of digestive surgery (except for appendicitis) affect drug absorption; 3. Activity in patients with hepatitis b or hepatitis c, hepatitis b virus carriers; 4. Positive find of HIV antibody; 5. Smoke more than five cigarettes a day, doubt or does history of drug abuse, alcohol intake 3 months more than a day on average two units (1 = 12 ounces or 360 ml beer, 5 ounces, or 150 ml of liquor, 1.5 ounces or 45 ml distilled spirits) or test positive for alcohol; 6. Rounding out the top three months, in another drug test or used the test drug; 7. Two weeks before the beginning of the experiment using any other drugs; 8. Clinically significant history of allergy, especially the history of drug allergy, especially for lamivudine and allergy to any ingredient in the supplementary material; 9. Three months before the test and offer a blood or blood loss is equal to or more than 500 mL, or going to the end of the test or during test within three months after donating blood or blood components; 10. Pregnant or breastfeeding women, or are pregnant may not acceptable contraceptive methods of women, or pregnancy test positive for and did not take effective contraceptive measures or their spouses program gave birth to six months; 11. Can't tolerate venipuncture blood; 12. Can't guarantee from 48 hours before taking the medicine to the front of the last blood banned smoking and serve grapefruit juice or any food and drinks containing alcohol and xanthine (including chocolate, tea, coffee, coke, etc.); 13. Researcher concludes that the subjects were unable to complete this study, or that the participants involved in this study the other condition that may cause damage.

Design outcomes

Primary

MeasureTime frame
Pulse;Respiration;Blood Pressure;ECG;Temperature;Blood Routine Examination;Routine Urine Examination;Blood Biochemical;

Countries

China

Contacts

Public ContactXinghe Wang

Beijing Shijitan Hospital Capital Medical University

wangxinghe@yahoo.com+86 10 63926401

Outcome results

None listed

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