An Open-Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Relative Bioavailability Study Comparing Test Product (T) C. longa Extract Formulation 60 percent (200 mg) with Reference Product (R) C. longa Extract 95 percent (1000 mg) in Healthy, Adult, Human Subjects Under Fasting Condition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To assess the comparative pharmacokinetic profile and bioavailability of a single oral dose of the
研究概览
简要总结
This open-label, balanced, randomized, single-dose, two-treatment, two-sequence, two-period, crossover bioavailability study aims to assess the comparative pharmacokinetic profile and bioavailability of two Curcuma longa extract formulations in healthy adult human subjects under fasting conditions. The study will compare a 60% curcuminoids formulation (200 mg) as the test product (T) with a 95% curcuminoids formulation (1000 mg) as the reference product (R), both manufactured by Chemiloids Life Sciences Pvt. Ltd., India. The primary objective is to evaluate the pharmacokinetic parameters, including Cmax and AUC0-t, while the secondary objective is to monitor the safety and tolerability of the formulations. The study will enroll 16 healthy subjects, with two additional subjects as reserves in case of dropout. The subjects will be randomly assigned to receive either the test or reference product in each of two periods, with a washout period of at least 7 days between doses. Randomization will be performed using a computer-generated sequence. The pharmacokinetic parameters will be analyzed using Non-Compartmental Analysis (NCA) with Phoenix WinNonlin Software or SAS® System, and the bioequivalence of the test product to the reference will be assessed through statistical analysis, including a two-way analysis of variance (ANOVA) model and geometric mean ratios (GMRs) for Cmax and AUC0-t. If the 90% confidence interval for GMR falls within 80-125%, the test product will be considered bioequivalent. Safety will be monitored through vital sign assessments, medical examinations, and laboratory tests, with adverse events (AEs) being recorded and managed appropriately. The study will be conducted in accordance with ICH GCP, ICMR guidelines, CDSCO regulations, and other applicable local standards, and ethical approval will be obtained before the study begins.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy human volunteers aged 18-45 years and weighing at least 50 kg.
- •2.Capable and willing to give informed written consent and adhere to study requirements.
- •3.BMI between 18.50–30.00 kg/m².
- •4.Healthy individuals based on personal history, medical history, and general medical examination.
- •5.No significant disease as judged by the investigator.
- •6.Normal biochemical, hematological, and urinary parameters, or clinically insignificant abnormalities (within 21 days prior to Period I check-in).
- •7.Normal 12-lead ECG or clinically insignificant abnormalities.
- •8.Negative for HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody, and VDRL.
- •9.Negative urine screening for drugs of abuse (Cannabinoids, Amphetamine, Barbiturates, Cocaine, Benzodiazepines, Morphine).
- •10.Negative breath alcohol test.
- •11.Non-smoker.
- •12.Non-alcoholic.
- •13.Ability to fast for at least 10 hours prior to dosing and 4 hours after dosing.
- •14.Ability to consume standard meals.
- •15.Ability to consume turmeric-free and black pepper-free food.
- •16.Willingness to adhere to protocol requirements and provide written informed consent.
- •17.Can provide adequate evidence of identity.
- •For Female Volunteers:
- •Negative pregnancy tests
- •Not pregnant, lactating, or attempting pregnancy 14.
排除标准
- •1.History of any significant medical disorder as determined by the investigator.
- •2.History of any major surgical procedure within the past 3 months.
- •3.History of being on dialysis.
- •4.History or presence of significant hematopoietic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urinary retention, severe gastrointestinal condition, myasthenia gravis, narrow-angle glaucoma, tachyarrhythmia, or psychiatric disorder.
- •5.History or presence of diabetes mellitus, tuberculosis, or systemic hypertension.
- •6.History or current use of medication for joint pain, inflammation, kidney stones, or urinary tract issues.
- •7.Recent history of dehydration due to diarrhea, vomiting, or any other cause within 24 hours prior to check-in.
- •8.History of dysphasia.
- •9.History or presence of cancer.
- •10.Difficulty in donating blood.
- •11.Personal or family history of muscular disorders.
- •12.Any deformity affecting venous access for cannulation.
- •13.History or presence of significant medical disorders as determined by the investigator.
- •14.History of alcohol consumption.
- •15.Habituation to coffee, tea, or other xanthine-containing products and inability to withhold intake.
- •16.Consumption of caffeine and/or xanthine products (e.g., coffee, tea, chocolate, caffeine-containing sodas) within 24 hours prior to check-in.
- •17.Consumption of tobacco-containing products, grapefruit, and its juice within 48 hours prior to check-in.
- •19.History of drug abuse.
- •20.History of allergy to vegetables, food substances, or any other hypersensitivity reactions.
- •21.Current or past use of medications that may modify the kinetics/dynamics of study medications or other medications deemed clinically significant by the investigator.
- •23.Positive screening test result for HIV, Hepatitis B, Hepatitis C, or VDRL.
- •24.Intake of OTC products, herbal medications, or similar within 7 days prior to check-in.
- •25.Intake of prescription medications within 14 days prior to check-in that may affect the study medications.
- •26.Unusual diet (e.g., low sodium) within 3 weeks prior to check-in.
- •27.Depot injection or drug implant within 3 months prior to study commencement.
- •28.Following a vegan diet.
- •30.Consumption of food containing curcumin or black pepper within 48 hours prior to dosing.
- •31.History or evidence of hypersensitivity to curcumin, Piperine, or their metabolites.
- •32.Any blood donation or excessive blood loss within 90 days of check-in.
- •For Female Volunteers:
- •Pregnant or lactating females, those planning to become pregnant, donate gametes during the study, or unwilling to use appropriate contraceptive methods during the study and for 3 weeks after the last study-related visit.
- •Female volunteers with a positive urine pregnancy test at screening, and a positive serum pregnancy test before check-in for each period and during the study.
结局指标
主要结局
To assess the comparative pharmacokinetic profile and bioavailability of a single oral dose of the
时间窗: In each period, total of 11 (1 x 06 mL) blood samples will be collected from each subject in K2EDTA vacutainers. The blood samples will be collected at 00.00 (pre-dose) within 02.00 hours prior to dosing and the post dose blood samples will be collected 00.50, 01.00, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose in each period.
Test Product (T) Curcuminoids Formulation 60% (200 mg) Manufactured by Chemiloids Life Sciences Private Limited, India with Reference Product (R) Curcuminoids unformulated 95% (1000mg) anufactured by Chemiloids Life Sciences Private Limited, India in Healthy, Adult,
时间窗: In each period, total of 11 (1 x 06 mL) blood samples will be collected from each subject in K2EDTA vacutainers. The blood samples will be collected at 00.00 (pre-dose) within 02.00 hours prior to dosing and the post dose blood samples will be collected 00.50, 01.00, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose in each period.
Human Subjects under Fasting Conditions
时间窗: In each period, total of 11 (1 x 06 mL) blood samples will be collected from each subject in K2EDTA vacutainers. The blood samples will be collected at 00.00 (pre-dose) within 02.00 hours prior to dosing and the post dose blood samples will be collected 00.50, 01.00, 02.00, 03.00, 04.00, 06.00, 08.00, 12.00, 16.00 and 24.00 hours post dose in each period.
次要结局
- To monitor the safety and tolerability of a single oral dose administered in Healthy, Adult, Human Subjects Under Fasting Condition.(Medical examination:)
研究者
Dr Shailender Singh Tanwar
BioRadius Therapeutic Research Pvt. Ltd.