Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ONRC-10000858
• Date of registration: 2010-04-28
• Prospective Registration: Yes
• Primary sponsor: Chinese PLA General Hospital
• Public title: Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide
• Scientific title: Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide
• Date of first enrolment: 2010-05-10
• Target sample size: Group A:15;GroupB:12;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8679
• Study type: Observational study
• Study design: Non randomized control
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Bai Nan
• Affiliation: Chinese PLA General Hospital

• Name: Wang Rui
• Affiliation: Chinese PLA General Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 2008L03398C-1: (healthy volunteer)
1. The voluntary to participate in clinical trials must be fully understand the test content and possible adverse reactions,and signed informed consent;
2. Healthy male, aged 35 to 45 years of age, must agree and commit to use a medically acceptable form of contraception during the screening period,throughout the study (including follow-up), and for at least 1 year after the last dose of test article;
3. Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 and body weight >=50 kg;
4. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray examination, and 12-lead electrocardiogram (ECG);
5. Without taking any other medicines at least 4 weeks;
6. Without heart, liver, kidney, gastrointestinal tract, nervous system, metabolic disorders and other medical history;
7. No history of drug and food allergies, no tobacco and alcohol habits;
8. Have a high probability for compliance with and completion of the study.
2008L03398C-2:(Ankylosing spondylitis)
1. Patients with 18 to 45 years of age, must agree and commit to use a medically acceptable form of contraception during the screening period, throughout the study (including follow-up), and for at least 1 year after the last dose of test article;
2. Diagnosis of AS according to the 1966 New York standards (see Annex 1), according to a recent shot of sacroiliac joint X film in 1 year, diagnosed as AS;
3. Selected patients during the active AS, defined as the duration of morning stiffness and strength in the mean of the visual analog scale (VAS) >=30 and to meet the following: VAS overall assessment of subjects >=30; The average pain VAS of night and the whole back >=30; or BathAS Functional Index (BASFI) >=30 (all scores within the 0-100 scale);
4. If screening of subjects is being used physical therapy such as acupuncture, physical therapy, infrared radiation, laser therapy, the treatment has been stable at least 2 weeks;
5. Screening of subjects into groups is oral diclofenac medication 7 days before the switch provided by the researchers of diclofenac sodium enteric-coated tablet, if the subjects are oral NSAIDs drugs other than diclofenac drugs, then 7 days before enrollment provided by the researchers into the use of diclofenac sodium enteric-coated tablets;
6. If patients are using remission drugs (such as sulfasalazine, methotrexate, etc.) should be discontinued at least 1 month.
Exclusion criteria: 2008L03398C-1:(healthy volunteer)
1. Presence or history of any disorder that may prevent the successful completion of the study;
2. Serious infection (infection associated with hospitalization and/or parenteral antimicrobial agents) within 6 months before test article administration or active infection at screening;
3.Personal or family history of autoimmune disease or a history of allergies;
4. Directly involved in the clinical trials research unit and their families;
5. Subjects had blood donation within one month before the study, or intended to have blood donation in the end of the study or during the study period within one month;
6. Subjects drinking more than 28 units of alcohol (1 unit = 285ml of beer or 25ml spirits or a glass of wine)weekly; subjects smoking more than five cigarettes per day (or the equivalent amount of tobacco);drinking alcohol in the48 hours before the first day of study;
7.Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine [PCP]);
8. 3 months before screening had received study drug, study drug was given to the first 4 weeks, the subjects being applied or have applied any prescription or buy their own drugs (including steroid drugs, etc.)
9. For any reason, the researchers believe that the subjects can not complete this study.
2008L03398C-2:(Ankylosing Spondylitis)

Age minimum: 18
Age maximum: 45
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Group A:Muti-dose Thalidomide;GroupB:Muti-dose Thalidomide and Diclofenac sodium enteric-coated tablets ;

Primary Outcome(s)

Plasma concentration;

Source(s) of Monetary Support

Changzhou Pharmaceutical Factory