NCT04889651已完成1 期
A Randomized, Open Label, Single Dose, Full Replicated Crossover Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables-Cmax
研究概览
简要总结
To compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects after a single-dose administration while fasting.
详细描述
This is a randomized, open label, single dose, full replicated crossover study to compare the pharmacokinetics and safety between BR9004 and BR9004-1 in healthy male subjects under fasting conditions. To this end, subjects were divided into two sequence groups [Sequence A (TRTR) & Sequence B (RTRT), T: BR9004, single oral administration, R: BR9004-1, single oral administration].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Those who voluntarily signed the Institutional Review Board(IRB)-approved informed consent to participate in this study after being given an sufficient explanation about the study objectives, details, and characteristics of the investigational product
- •Healthy males aged between 19 and 55 at the time of the screening test
- •Those who weigh over 50 kg with BMI of 18.0 to 30.0 BMI (kg/m2) = Weight(kg) / [Height(m)]2
排除标准
- •Those who had a clinically significant medical history such as hypersensitivity reaction, intolerance, and anaphylaxis against Abiraterone which is the main ingredient of the investigational products.
- •Those who had clinically significant diseases in the liver, kidneys, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, hematologic, oncologic, and cardiovascular disorders (including orthostatic hypotension), etc.
- •Those who had gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, etc.) that may affect the absorption of the investigational products or underwent surgeries (excluding appendectomy, hernia surgery, endoscopic removal of polys, and surgeries for piles, anal fissure, anal fistula)
- •Those who were judged to have clinically significant abnormal results in the interview, vital signs, ECG, physical examinations, blood & urine test, etc. during the screening test
- •Those who showed positive results in HBsAg, hepatitis C virus(HCV) Ab, HIV Ab, and rapid plasma reagin(RPR) test during the screening test
- •Those who showed one of the following results during the screening test:
- •Aspartate aminotransferase(AST) or Alanine aminotransferase(ALT) higher than 2 times the upper limit of normal range
- •T. bilirubin higher than 2 times than the upper limit of normal range
- •Estimated Glomerular Filtration Rate(e-GFR) lower than 60 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI))
- •Those who showed > 150 mmHg or < 90 mmHg of systolic blood pressure or > 95 mmHg or < 60 mmHg of diastolic blood pressure during the screening test
- •Those who did not agree to stop taking prohibited drugs (prescription drugs, over-the-counter drugs, herbal medicines or nutritional supplements, e.g., vitamins) within 2 weeks after the administration of investigational products (accepted if the investigator judges that the drug may not affect the safety of the subject and study results)
- •Those who had drug abuse (especially drugs that affect the central nervous system such as sleeping pills, analgesics that work on the central nervous system(CNS), narcotic drugs, or psychoactive drugs) or have a history of drug abuse
- •Those who had a continuous intake of alcohol that exceeds 21 units/week (1 unit=10g=12.5mL) within 6 months of the screening
- •☞ Amount of alcohol(g) = Amount of intake (ml) x Alcohol degree (%) x 0.8* (*10g=12.5mL)
- •Those who smoked over 10 cigarettes a day within 6 months of the screening
- •Those administered with the investigational products by participating in other clinical studies within 180 days before the first administration of the investigational products (however, the day after the last administration date is considered Day 1 after the previous study participation ends)
- •Those who donated whole blood within 8 weeks and plasma or platelet within 4 weeks before the first administration of the investigational products or who did not agree to stop donating blood donation for 30 days from the date when the investigational products are administered
- •Those who did not agree to stop having foods diets (especially those containing grape fruit-containing foods) that may affect the absorption, distribution, metabolism, and excretion of the investigational products from 3 days before the first administration until the last visit
- •Those who did not agree to use clinically accepted contraceptive methods (e.g., contraceptive pills, intrauterine devices, sterilization procedures(vasectomy, and tubal ligation) or barrier methods (combined use of spermicide and condom, contraceptive diaphragm, vaginal sponge or cervical cap)) for at least 3 weeks after the last administration from the first administration of investigational products.
- •Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, etc.
- •Those undergoing combined therapy with radium-223 chloride
- •Those whom the investigator judges unsuitable for participation in this study for other reasons
研究组 & 干预措施
A(TRTR)
Experimental
The selected subjects are randomized into two sequence group(Sequence A (TRTR) & Sequence B (RTRT)).
* Sequence A: T-R-T-R
- T: BR9004, oral single-dose administration, 1 tablet per day
- R: BR9004-1, oral single-dose administration, 1 tablet per day
- Washout interval between periods: 7 days
干预措施: BR9004 (Drug)
A(TRTR)
Experimental
The selected subjects are randomized into two sequence group(Sequence A (TRTR) & Sequence B (RTRT)).
* Sequence A: T-R-T-R
- T: BR9004, oral single-dose administration, 1 tablet per day
- R: BR9004-1, oral single-dose administration, 1 tablet per day
- Washout interval between periods: 7 days
干预措施: BR9004-1 (Drug)
B(RTRT)
Experimental
The selected subjects are randomized into two sequence group(Sequence A (TRTR) & Sequence B (RTRT)).
* Sequence B: R-T-R-T
- T: BR9004, oral single-dose administration, 1 tablet per day
- R: BR9004-1, oral single-dose administration, 1 tablet per day
- Washout interval between periods: 7 days
干预措施: BR9004 (Drug)
B(RTRT)
Experimental
The selected subjects are randomized into two sequence group(Sequence A (TRTR) & Sequence B (RTRT)).
* Sequence B: R-T-R-T
- T: BR9004, oral single-dose administration, 1 tablet per day
- R: BR9004-1, oral single-dose administration, 1 tablet per day
- Washout interval between periods: 7 days
干预措施: BR9004-1 (Drug)
结局指标
主要结局
Pharmacokinetic variables-Cmax
时间窗: 1~22 days after medication
Maximum observed plasma concentration(Cmax) of BR9004 and BR9004-1
Pharmacokinetic variables-AUClast
时间窗: 1~22 days after medication
Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration(AUClast) of BR9004 and BR9004-1
次要结局
- Pharmacokinetic variables-AUCinf(1~22 days after medication)
- Pharmacokinetic variables-Tmax(1~22 days after medication)
- Pharmacokinetic variables-t1/2β(1~22 days after medication)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate Drug-drug Interactions Between BR9006-1 and BR9006-2 in Healthy Male Volunteers.Benign Prostatic Hyperplasia (BPH)Overactive BladderNCT04485585Boryung Pharmaceutical Co., Ltd36
已完成
1 期
A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy VolunteersChronic Heart FailureNCT05102903Boryung Pharmaceutical Co., Ltd60
已完成
1 期
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy VolunteersHepatocellular CarcinomaNCT05068193Boryung Pharmaceutical Co., Ltd57
已完成
1 期
A Clinical Trial Study to Evaluate the Pharmacokinetic Interaction and Safety Between BR1019-1 and BR1019-2 in Healthy Adult SubjectsHypertensionDiabetes Mellitus, Type 2NCT05875259Boryung Pharmaceutical Co., Ltd36
已完成
1 期
A Study to Evaluate Drug-drug Interactions Between BR1017-1 and BR1017-2 in Healthy VolunteersHypercholesterinemiaHypertensionNCT05372380Boryung Pharmaceutical Co., Ltd32