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Bioequivalence of Lenalidomide capsules to healthy Chinese male volunteers in an open-label, randomised, single-dose, after the meal, two-way crossover study

Bioequivalence of Lenalidomide capsules to healthy Chinese male volunteers in an open-label, randomised, single-dose, after the meal, two-way crossover study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006280
Enrollment
Unknown
Registered
2015-03-23
Start date
2015-03-10
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

Multiple myeloma

Interventions

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
25 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. age: 25 to 45 years old, include 25 and 45; 2. the gender: male; 3. the participants have children, there is no family planning again; 4. at further 50 Kg body weight, body mass index of 19 the or and 24 Kg/m2 or less healthy adults; 5. test before the medical history, physical examination, laboratory projects all inspection, testing and test related to normal or mildly abnormal without clinical significance, clinical doctors judge considered eligible; 6. have signed a written informed consent of the subjects; 7. Subjects in the last delivery within 3 months after the end of free blood donation program; 8. Subjects were no sperm donation program.

Exclusion criteria

Exclusion criteria: 1. Has a history of severe system diseases, especially hypertension medical history, history of blood clots, long-term smoking history, history of hyperlipidemia, or may lead to other related history of blood clots; 2. In drug delivery within 48 hours before taking a special diet (including the dragon fruit, mango, pomelo, and/or xanthine diet, chocolate and caffeinated coffee or tea, or any food or drinks containing caffeine, etc.) or strenuous exercise, or other affect drug absorption, distribution, metabolism and excretion; 3. For the drug lenalidomide or other immunomodulatory drugs has a history of allergy or intolerance; 4. has a history of allergies to other drugs, or biological agents; 5. Have a mental illness, suicide attempts, or ever; 6. in the first time to accept too much within 4 weeks before surgery; 7. for the first time in drug delivery within 4 weeks before any live vaccine inoculation; 8. In the past five years has a history of drug abuse; 9. in the group of four weeks before using any prescription drugs, or into groups within 1 week before use over-the-counter medications or herbal, unless otherwise agreed by the medical monitoring drug cleared; 10. Within 6 months before the first delivery or frequent drinkers during test, namely, drinking more than 14 units of alcohol a week; 11. In the first 3 months before the dosing daily smoking more than 1, or used any tobacco products during the test; 12. As the subjects participated in nearly a year 3 times or more than 3 times drug clinical subjects; 3 months prior to the test as the subjects to participate any drug clinical trials, or 3 months once blood donors, blood donors, or plan to three months before the test had a transfusion in 4 weeks; 13. Did not take effective contraceptive measures or have family planning of the subjects; 14. researchers say adherence is poor, or has any unfavorable factors to participate in the test subjects; 15. The researchers and their family members; 16. may be for some other reason that you can't accomplish the subjects of this study.

Design outcomes

Primary

MeasureTime frame
Pulse;Respiration;Blood Pressure;ECG;temperature;

Countries

China

Contacts

Public ContactXinghe Wang
wangxinghe@yahoo.com+86 010-63926401

Outcome results

None listed

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