Aminocaproic acid Tablets 1000 mg BE Fed Study

Not Applicable

• Registration Number: CTRI/2019/05/018932
• Lead Sponsor: Optimus Pharma Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

i. Subjects who are able to understand and provide written informed consent.

ii. Subjects must be healthy, adult, human beings within 19-35 years of age (both inclusive) weighing at least 50 kgs.

iii. Having a Body Mass Index (BMI) between 18.50 and 24.90 (both inclusive), calculated as weight in Kg/ (height in m)2.

iv. 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).

ix. Female study participant should be negative for serum pregnancy test at screening, check-in for all periods and post study.

Exclusion Criteria

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 conditionsTimepoint: 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

Secondary Outcome Measures

Name	Time	Method
2.To evaluate the subject safety and tolerability of the investigational products.Timepoint: 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