An open label, balanced, randomized, truncated, single dose, two treatment, two sequence, two period, crossover, oral bioequivalence study of Ursodeoxycholic Acid Tablet 500 mg by Fourrts (India) Laboratories Pvt. Limited with Ursofalk 500mg tablets (Ursodeoxycholic Acid) of Dr. Falk Pharma GmbH, Germany., in healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of Ursodeoxycholic Acid Tablet
研究概览
简要总结
Descriptive statistics of primary and secondary pharmacokinetic parameters will be computed and reported for Baseline corrected and uncorrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol in plasma. ANOVA, 90% confidence interval using schuirmann’s two one-sided tests for bioequivalence, power and ratio analysis, for ln-transformed pharmacokinetic parameters Cmax and AUC0-72 will be computed and reported for Baseline corrected and uncorrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol.
BE Criteria: Based on the statistical results of 90% confidence interval for the ratio of the geometric least squares means for lntransformed pharmacokinetic parameters Cmax and AUC0-72 for Baseline corrected and uncorrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol, 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 lntransformed pharmacokinetic parameters Cmax and AUC0-72 for Baseline corrected Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol. Note: Baseline Correction Method The mean of the pre-dose Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol levels should be used for the baseline adjustment of the post-dose levels. Baseline concentrations should be determined for each dosing period, and baseline corrections should be period specific. If a negative plasma concentration value results after baseline correction, this should be set to 0 prior to calculating the baseline-corrected AUC. The Unconjugated ursodiol and total (conjugated and unconjugated) ursodiol pharmacokinetic parameters should be determined based on both baselinecorrected and baseline un-corrected plasma concentration data
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- •Willing to be available for the entire study period and to comply with protocol requirements.
- •Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
- •Body mass index in the range of 18.5 – 30.0 kg/m2 (both inclusive).
- •Healthy volunteers who are clinically non-anemic will be included as per the discretion of PI/CI/Physician.
- •Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate and axillary temperature) measurements at the time screening as well as check-in during check-out of each study period.
- •With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis.
- •With a normal or clinically non-significant 12-lead ECG.
- •With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
- •Non-smokers and willing to abstain from smoking or chewing any tobacco containing product at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points.
- •Male volunteer willing to use appropriate contraceptive measures to ensure that his female partner will not get pregnant for at least 15 days before 1st dosing till 15 days post last-dose/ entire study period.
- •In case of female subjects: 13) Negative urine pregnancy test during screening and negative serum beta -hCG test at check-in of each study period.
- •Female subjects with childbearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse or using acceptable methods of birth control for at least 15 days before 1st dosing till 15 days post last-dose/ entire study period [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) has been performed].
- •Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
排除标准
- •Incapable of understanding the informed consent information.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •History or presence of severe renal dysfunction, including those receiving dialysis and hepatic dysfunction.
- •History or presence of active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities 5) History or presence of pre-existing gallbladder disease.
- •History or presence of mortality and coronary heart disease morbidity 7) Use of antihypertensive drugs and pressor Agents (e.g. dopamine, dobutamine), use of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine), use of monoamine oxidase Inhibitors in the previous 30 days before first drug administration and till the completion of the study.
- •History or presence of asthma, urticaria or other allergic reactions.
- •History or presence of gastric and/or duodenal ulceration.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •History or presence of cancer.
- •Difficulty with donating blood.
- •Difficulty in swallowing solids like tablets.
- •Use of any prescribed medication (including herbal medicines, vitamin supplements, Bile Acid Sequestering Agents and Aluminium based Antacids) during the two weeks before the start of the study or vitamins, herbal products and OTC medicinal products during two weeks prior to study initiation.
- •Subject chewed tobacco / consumed pan or pan masala, gutkha, masala (containing beetle nut and tobacco), xanthine-containing foods or beverages (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc) for 48.00 hours prior to initiation of the study till the end of the study.
- •Subjects consumed grapefruit juice and poppy containing foods for 72.00 hours prior to initiation of the study till the end of the study.
- •Subjects consumed alcohol or alcoholic products for at-least 24.00 hrs prior to check-in in each study period and throughout sampling time points 18) Major illness during the 180 days before screening.
- •Donation of blood within 90 days of screening.
- •Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
- •Positive result for urinary screen test for drugs of abuse (amphetamines, morphine, benzodiazepines, marijuana, cocaine and barbiturate).
- •Subjects with positive test results for urine pregnancy test for female subjects.
- •History or presence of easy bruising or bleeding.
- •Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein, low sodium diets etc.
- •Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- •A depot injection or implant of any drug within 3 months prior to the first dose of study medication.
- •Pregnant woman and nursing mothers.
- •History of allergy or hypersensitivity intolerance to Ursodeoxycholic acid or its formulation excipients which, in the opinion of the clinical investigator, would compromise the safety of the subject or the study.
- •Evidence of an uncooperative attitude.
结局指标
主要结局
To compare the rate and extent of absorption of Ursodeoxycholic Acid Tablet
时间窗: The venous blood samples will be withdrawn at pre-dose (-24.00, -18.00, -12.00, -6.00 and 0.00 hours) and at 0.12, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post dose following drug administration in each period.
500 mg by Fourrts (India) Laboratories Pvt. Limited with Ursofalk 500mg tablets
时间窗: The venous blood samples will be withdrawn at pre-dose (-24.00, -18.00, -12.00, -6.00 and 0.00 hours) and at 0.12, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post dose following drug administration in each period.
(Ursodeoxycholic Acid) of Dr. Falk Pharma GmbH, Germany., in healthy, adult,
时间窗: The venous blood samples will be withdrawn at pre-dose (-24.00, -18.00, -12.00, -6.00 and 0.00 hours) and at 0.12, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post dose following drug administration in each period.
human subjects under fasting conditions
时间窗: The venous blood samples will be withdrawn at pre-dose (-24.00, -18.00, -12.00, -6.00 and 0.00 hours) and at 0.12, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 24.00, 48.00 and 72.00 hours post dose following drug administration in each period.
次要结局
- To monitor the safety and tolerability of the study subjects after administration(of Ursodeoxycholic Acid Tablet 500 mg in healthy, adult, human subjects, under)
研究者
Dr Lakshmikar B V
ICBio Clinical Research Private limited