CTRI/2025/11/097849尚未招募不适用
An Open label, balanced, randomized, multi-center, two-treatment, two-period, two-sequence, multiple dose, steady state, crossover, oral bioequivalence study of Olaparib 150 mg Tablets by SP Accure Labs Private Limited with Lynparza 150 mg Tablet (Olaparib) of AstraZeneca Pharmaceuticals LP., in female patients with deleterious or suspected deleterious germline BRCA-mutated advanced metastatic breast cancer under fasting condition.
Intercontinental Pharma3 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年12月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 3
研究概览
简要总结
Descriptive statistics of primary and secondary pharmacokinetic parameters will be computed and reported for Olaparib.
ANOVA, 90% confidence interval using schuirmann’s two one-sided tests for bioequivalence, power and ratio analysis, for ln-transformed pharmacokinetic parameters CmaxSS and AUC0-tau will be computed and reported for Olaparib.
Based on the statistical results of 90% confidence interval for the ratio of the geometric least squares means for ln-transformed pharmacokinetic parameters CmaxSS and AUC0-tau will be computed and reported for Olaparib, conclusion will be drawn for Test Product-T vs. Reference Product-R.
Bioequivalence of the test product with that of the reference product will be concluded if 90% confidence interval falls within the acceptance range of 80.00-125.00% for ln-transformed pharmacokinetic parameters CmaxSS and AUC0-tau will be computed and reported for Olaparib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients on treatment with advanced metastatic breast cancer.
- •Patients that are already receiving a stable dose of olaparib tablets (2 x 150 mg tablets) 300 mg twice daily for at least 10 days.
- •Patients requiring Olaparib in the dose of 300 mg (2 x 150 mg tablets) twice daily as per the discretion of the Investigators, these patients will be stabilized on Olaparib as a part of study and those patients that tolerate Olaparib in the dose of 300 mg twice daily for 10 days will be randomized in the study.
- •Maintenance treatment of adult patients with advanced metastatic Breast cancer (adenocarcinoma) who are in complete or partial response to first line chemotherapy.
- •Patients have an estimated survival of at least 3 months.
- •Non-smoking, non-pregnant, non-lactating female patient with a body mass index in the range of
- •50 – 30.00 kg/m2 (both inclusive).
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •Subjects with adequate laboratory values as determined at the time of eligibility assessment.
- •Patients with ECOG performance status of 0-2 (Attachment 01).
- •Patients with absence of blood transfusion in the 28 days prior to randomization.
- •Women of non-childbearing potential with documented evidence of hysterectomy/ bilateral salpingectomy/ bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months.
- •Or 14) Women of child bearing potential must have negative Urine pregnancy test at screening visit and negative serum beta-hcG test during check-in and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to drug administration] sexual partner) for at least 4 weeks prior to drug administration, during the study and up to 6 months after the last dose of drug administration.
- •Cessation of birth control after this point should be discussed with a responsible physician.
- •With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
- •Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
排除标准
- •History of known hypersensitivity to Olaparib or its components which in the opinion of the Investigator would compromise the safety of the patient or the results of the study.
- •Patients found positive for HIV Syphilis Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •Have ongoing clinically significant adverse events due to prior treatments administered as determined by the Investigator.
- •History of other malignancies in the last five years.
- •Patients with Pneumonitis.
- •Patients with severe hepatic impairment Child Pugh classification category C.
- •Patients who received any chemotherapy radiotherapy or any other anticancer therapy within four weeks from the last dose prior to first dosing in Period 01 or a longer period depending on the defined characteristics of the agents used.
- •History or presence of any active infection or uncontrolled systemic disease for example cardiovascular disease hypertension diabetes mellitus etc or any clinically significant disease condition disorder or abnormal laboratory finding that in the opinion of the Investigator may either put the patient at risk because of participation in the study or influence the study results or the patient ability to participate in the study.
- •Patients had major surgery within four weeks prior to first dosing in Period 01 or who have not recovered from prior major surgery.
- •In the opinion of the Investigator the patient will not be compliant with the requirements of the study procedures.
- •Receipt of an investigational medicinal product or participation in another drug research study involving drug administration within thirty days prior to first dosing in Period 01 for the current study.
- •Usage of strong and moderate CYP3A4 inhibitors for example cimetidine ciprofloxacin grapefruit juice or strong and moderate CYP3A4 inducers for example carbamazepine phenytoin St Johns Wort rifampicin within thirty days prior to first dosing in Period 01 refer Attachment 02 for a full list of prohibited medications.
- •History of difficulty in accessibility of veins or intolerance to direct venipuncture.
- •Pregnant or lactating females.
- •Patient with positive test result on Breath alcohol analyzer test at the time of baseline or randomization visit.
- •Positive on urine test for drugs of abuse including amphetamines barbiturates benzodiazepines marijuana cocaine and morphine prior to receiving the first dose of investigational medicinal product in the study.
- •History or presence of alcoholism or drug abuse.
- •Patients with psychiatric illness or social situations that would limit compliance with study requirements.
- •Difficulty in swallowing tablets.
- •Patients having problems with fasting restriction.
- •History or presence of clinically significant lactose galactose or fructose intolerance.
- •Participated in any clinical investigation requiring repeated blood sampling blood donation or have blood loss of more than five hundred millilitres in past ninety days prior to dosing.
- •Participated in any clinical study within the past ninety days prior to first dosing.
- •Consumption of alcohol or alcoholic products within twenty four hours prior to dosing in each study period and throughout sampling time points.
- •Positive alcohol breath or urine screen for drug of abuse tests during check in in each study period.
- •Consumption of xanthine or its derivative containing food or beverages for example chocolates tea coffee or cola drinks within forty eight hours prior to dosing in each study period and throughout sampling time points.
- •Consumption of grapefruit or its juice within seventy two hours prior to dosing in each study period and throughout sampling time points.
- •Incapable of understanding the informed consent information.
- •Evidence of an uncooperative attitude.
研究者
Dr Lakshmaiah KC
Srinivasam Cancer Care Multi-Speciality Hospital
研究点 (3)
Loading locations...
相似试验
尚未招募
不适用
A study to compare the absorption of two oral formulations of the same medicine in healthy adults under fasting conditions.CTRI/2025/09/095295Fourrts (India) Laboratories Pvt. limited26
尚未招募
不适用
A Study to Compare the Bioequivalence of Two Metformin 1000 mg Extended-Release Tablets in Healthy Adults Under Fed ConditionsCTRI/2025/09/095284Laboratorios Leti, S.A.V32
尚未招募
不适用
A study to compare how the body absorbs and processes two brands of Ursodeoxycholic Acid 500 mg tablets in healthy adults under fasting conditionsCTRI/2025/09/095163Fourrts (India) Laboratories Pvt. limited12
已完成
不适用
An Open Label Single Dose Study To Evaluate Creneuros CNS Fish Oil Plus Softgels in Healthy Subjects Under Fasting ConditionsCTRI/2026/02/103386Sichuan Credit Pharmaceutical Co Ltd32
已完成
不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Pharmacokinetic Study Comparing Cinnamon Bark Extract 15 Mg Cinnamaldehyde CapsuleCTRI/2024/09/074434Nutriventia Limited12