An open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, two-way, crossover, oral bioequivalence study of Aminocaproic acid Tablets, 1000 mg of Optimus Pharma Private Limited with AMICAR® (aminocaproic acid) Tablets, 1000 mg Marketed by Clover Pharmaceuticals Corp. Marietta, GA 30062 in healthy, adult, human subjects under fed conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 1.To compare the bioequivalence of Aminocaproic acid Tablets, 1000 mg of Optimus Pharma Private Limited with AMICAR® (aminocaproic acid) Tablets, 1000 mg Marketed by Clover Pharmaceuticals Corp. Marietta, GA 30062 in healthy, adult, human subjects under fed conditions
研究概览
简要总结
Volunteers were being informedfor screening and study participation. The selected healthy volunteers afterscreening will be informed to visit the facility for informed consent process.
The interested volunteers who arewilling to participate in the study will be informed to report to the facility.Medical examination, vitals, breath alcohol analysis and urine drug screeningwill be performed for the volunteers who reports for the check-in process.
Inclusion and exclusion criteriawill be evaluated and the volunteers will be recruited into the study by theinvestigator for Period-I. After completion of check-in of Period-I subjectswill be provided pre-dose dinner and allowed to rest.
On dosing day subjects will be checked for vitalsand cannulation will be performed. Dosing will be given to the subjectsappropriately. Blood sample will be collected from subjects as per time pointsmentioned in Protocol.
Vitals will be measured atspecific time as provided in Protocol. Meals (Lunch, Snacks and dinner) will beprovided as per Protocol. Subjects will be in-house till completion of samplesand will be checked out after medical examination and vitals after collectionof last blood sample in Period-I.
The same process for Period-IIwill be carried out from check-in to check-out and a post study sample will becollected along with last study sample. If any abnormality observed in poststudy sample, subject will be followed up till resolution or declared as lostto follow up.
The test product will beconsidered as bioequivalent to the reference product if the 90% CI (Confidenceinterval) for the geometric least square mean ratios of ln-transformedparameters Cmax, AUC0-t and AUC0-inf of Aminocaproic acid falls within theacceptance range of 80.00-125.00%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are able to understand and provide written informed consent.
- •Subjects must be healthy, adult, human beings within 19-35 years of age (both inclusive) weighing at least 50 kgs.
- •Having a Body Mass Index (BMI) between 18.50 and 24.90 (both inclusive), calculated as weight in Kg/ (height in m)
- •Subjects must be of normal health as determined by medical history and physical examination performed within 28 days prior to the dosing (Exclude the day of check-in and dosing) of 1st period.
- •v.Have normal ECG, chest X-ray and vital signs (Oral Temperature 95 0F to 99 0F , Respiratory Rate-14 to 20 Per Minute, Pulse Rate -60 to 100 per minute, Systolic blood pressure-90 to 140 mm/Hg and Diastolic blood pressure-60 to 90 mm/Hg).
- •vi.Subjects whose screening laboratory values are within normal limits or laboratory abnormalities considered by the investigator to be of no clinical significance.
- •vii.Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent.
- •viii.If study participant is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) Or abstinence Or is postmenopausal for at least 1 year or is surgically sterile (bilateral tubal ligation, bilateral Oophorectomy or hysterectomy has been performed on the study participant).
- •Female study participant should be negative for serum pregnancy test at screening, check-in for all periods and post study.
排除标准
- •i.History of hypersensitivity or idiosyncratic reaction to Aminocaproic acid or any other related drugs.
- •ii.Subjects with history or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric diseases.
- •iii.Subjects positive for HIV antibody, HCV and Hepatitis B surface antigen.
- •iv.Consumption of grapefruit juice 03 days prior to the Initiation of the study and until the completion of the study.
- •v.Subjects who have taken over the counter (OTC) or prescribed medications or (Including Herbal Preparation)any systemic medication during the last 07 days and use of MAOI (Mono Amino Oxidase Inhibitors) within 14 days prior to study admission and till completion of the study.
- •vi.Study participants who have participated in any other clinical investigation using experimental drug or had blood loss of more than 350 mL at single occasion in the past 90 days.
- •vii.History of chronic alcoholism, chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of Ghutka, panmasala and tobacco products.
- •viii.Study participants with positive breath alcohol analysis, positive urine screen for drugs of abuse at the time of check-In for the study.
- •ix.Subject who are suffering from Diarrhea in the last 24.00 hours which leads to dehydration.
- •x.Female subjects who are pregnant (women with childbearing potential) or planning to become pregnant during the study.
- •xi.Female volunteers who are currently breast feeding.
结局指标
主要结局
1.To compare the bioequivalence of Aminocaproic acid Tablets, 1000 mg of Optimus Pharma Private Limited with AMICAR® (aminocaproic acid) Tablets, 1000 mg Marketed by Clover Pharmaceuticals Corp. Marietta, GA 30062 in healthy, adult, human subjects under fed conditions
时间窗: 0.00 hrs, 0.25 hrs, 0.50 hrs, 0.75 hrs, 1.00 hrs, 1.25 hrs, 1.50 hrs, 1.75 hrs, 2.00 hrs, 2.25 hrs, 2.50 hrs, 2.75 hrs, 3.00 hrs, 4.00 hrs, 5.00 hrs, 6.00 hrs, 8.00 hrs, 10.00 hrs and 12.00 hrs
次要结局
- 2.To evaluate the subject safety and tolerability of the investigational products.(0.00 hrs, 0.25 hrs, 0.50 hrs, 0.75 hrs, 1.00 hrs, 1.25 hrs, 1.50 hrs, 1.75 hrs, 2.00 hrs, 2.25 hrs, 2.50 hrs, 2.75 hrs, 3.00 hrs, 4.00 hrs, 5.00 hrs, 6.00 hrs, 8.00 hrs, 10.00 hrs and 12.00 hrs)