ISRCTN54640699已完成1 期
Single-dose oral bioequivalence study of primaquine phosphate tablets USP 15 mg (test) and primaquine 15 mg tablet (reference) in healthy adult human subjects under fasting conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38840151/ (added 11/06/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18 to 45 years old, both inclusive
- •2. Male or non-pregnant, non-lactating female
- •2.1. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test performed within 28 days prior to the first dosing day. They must be using an acceptable form of contraception.
- •2.2. For females of childbearing potential, acceptable forms of contraception include the following:
- •2.2.1. Non-hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- •2.2.2. Barrier methods containing or used in conjunction with a spermicidal agent, or
- •2.2.3. Surgical sterilization or
- •2.2.4. Practicing sexual abstinence throughout the course of the study
- •2.3. Females will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
- •2.3.1. Postmenopausal with spontaneous amenorrhea for at least 1 year, or
- •2.3.2. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •2.3.3. Total hysterectomy and an absence of bleeding for at least 3 months
- •3. BMI: 18.5 to 30.0 kg/m², both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5)
- •4. Able to communicate effectively with study personnel
- •5. Willing to provide written informed consent to participate in the study
- •6. Non-smokers and non-tobacco users (i.e. having no past history of smoking and tobacco consumption for at least 1 year prior to the study)
- •7. All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
- •7.1. A physical examination (clinical examination) with no clinically significant finding
- •7.2. Results within normal limits defined site normal range for the following tests:
- •7.2.1. Hematology: haemoglobin, total RBC count, total WBC count, platelet count, differential leukocyte count: neutrophils, lymphocytes, eosinophils, monocytes, basophils, blood indices: HCT, glucose-6-phosphate dehydrogenase (G6PD)
- •7.2.2. Biochemistry: BUN, serum creatinine, random glucose, SGPT & SGOT, alkaline phosphatase, uric acid, serum bilirubin, serum total protein: total proteins, albumin, serum electrolytes: serum sodium, serum chloride, serum potassium, serum phosphorous, serum calcium
- •7.2.3. Urinalysis: colour, quantity, specific gravity, odour, appearance, reaction, albumin, bilirubin, ketone bodies, sugar, urobilinogen and microscopical examination (performed based on clinical judgment)
- •7.2.4. Immunological tests: HIV-I & II, HBsAg, syphilis (RPR), anti HCV
- •7.2.5. Serum (ß-HCG) pregnancy test (for females of childbearing potential)
- •7.2.6. Additional tests and/or examinations (apart from those mentioned in the protocol) may be performed, if necessary, based on the principal investigator's discretion
- •7.2.7. All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation
排除标准
- •1. History of allergic responses to primaquine or other related drugs, or any of its formulation ingredients
- •2. Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, and, for females, gynaecological history
- •3. Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system
- •4. History or presence of bronchial asthma
- •5. Use of any hormone replacement therapy within 3 months prior to the first dose of study medication
- •6. A depot injection or implant of any drug within 3 months prior to the first dose of study medication
- •7. Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see http://medicine.iupui.edu/clinpharm/ddis/main-table)
- •8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use
- •9. History of difficulty with donating blood or difficulty with the accessibility of veins
- •10. A positive hepatitis screen (includes subtypes B & C)
- •11. A positive test result for HIV antibody and/or syphilis (RPR)
- •12. Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication
- •13. Volunteers who have donated blood or lost blood: 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to the first dose of study medication, whichever is greater
- •14. History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption
- •15. Intolerance to venepuncture
- •16. Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study
- •17. Institutionalized volunteers
- •18. Use of any prescribed medications within 14 days prior to the first dose of study medication
- •19. Use of any OTC products, vitamin and herbal products, etc, within 7 days prior to the first dose of study medication
- •20. Use of grapefruit and grapefruit-containing products within 7 days prior to the first dose of study medication
- •21. Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc), recreational drugs, alcohol or other alcohol-containing products within 48 hours prior to the first dose of study medication
- •22. Ingestion of any unusual diet, for whatever reason (e.g. low sodium) for 3 weeks prior to the first dose of study medication
- •23. Volunteers with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •24. Volunteers with a family or personal history of hemolytic anemia
研究者
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