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The bioavailability and bioequivalence study of Temozolomide for injection

The bioavailability and bioequivalence study of Temozolomide for injection

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006281
Enrollment
Unknown
Registered
2015-03-23
Start date
2015-04-20
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

Glioma

Interventions

Group A:Temozolomide capsule -Refference
Group B:Temozolomide capsule -T

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. The imaging and pathological histology and/or cytology diagnosis of glioblastoma and anaplastic astrocytoma and other participants contains acceptable for mo thiazole amine solution treatment of tumor subjects; 2. Age 18-60 years old (including threshold), gender not limited; 3. KPS score 60 or more points; 4. Expected lifetime is more than 3 months; 5. ANC>1.5*10^9/L, PLT>100*10^9/L, HGB>90g/L; 6. ALT<3ULN, AST <3 ULN, TBIL<1.5 ULN, Cr <1.5 ULN; 7. Sterilization surgery, after menopause or agreed to in the study and research during the period after the end of treatment using an approved within six months of physical contraception birth control (such as a house or a condom), and sign the subjects in clinical trials should be avoided during pregnant notice "(hereinafter referred to as birth control guidelines, appendix 1) female subjects;Sterilization surgery or agreed to in the study and research during the period after the end of treatment using an approved within six months of physical contraception, and sign the subjects in clinical trials should be avoided during pregnant notice" male subjects; 8. Test details before the nature, significance, may benefit, inconvenience and potential risk, understand the research program and voluntary signed informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation women; 2. The glass type of allergy to alkylating agent; 3. Unable to swallow or always accept the urea nitrate class alkylating agent severe vomiting; 4. Four weeks before the beginning of the experiment cytotoxic drugs chemotherapy; 5. Can't control epilepsy with author; 6. Unable to control high blood pressure, high blood sugar; 7. Have obvious intestinal obstruction, gastrointestinal bleeding, or present diarrhea; 8. Has a history of chronic bowel disease, stomach or intestinal resection; 9. Can't cooperation, can't communicate with the normal person; 10. Participated in other clinical subjects within 30 days; 11. 2 months prior to test blood or blood donation amount more than 200 ml; N ot suitable for participants'.

Design outcomes

Primary

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

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