| CTRI Number |
CTRI/2019/05/018932 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Aminocaproic acid Tablets 1000 mg BE Fed Study
|
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 113/18 Protocol Version No: 01 18 Mar 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A V Subbareddy |
| Designation |
Principal Investigator |
| Affiliation |
ActimusBiosciences |
| Address |
D-2
D-block
Autonagar
Visakhapatnam
ANDHRA PRADESH
530012
India |
| Phone |
|
| Fax |
|
| Email |
subbareddy@actimusbio.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A V Subbareddy |
| Designation |
Principal Investigator |
| Affiliation |
ActimusBiosciences |
| Address |
D-2
D-block
Autonagar
ANDHRA PRADESH
530012
India |
| Phone |
|
| Fax |
|
| Email |
subbareddy@actimusbio.com |
|
Details of Contact Person
Public Query
|
| Name |
A V Subbareddy |
| Designation |
Principal Investigator |
| Affiliation |
ActimusBiosciences |
| Address |
D-2
D-block
Autonagar
ANDHRA PRADESH
530012
India |
| Phone |
|
| Fax |
|
| Email |
subbareddy@actimusbio.com |
|
|
Source of Monetary or Material Support
|
| Optimus Pharma Pvt Ltd
Plot No. 73/B 73/B/2
EPIP
Pashamylaram (Village)
Patancheru (Mandal),
Sangareddy (District)
|
|
|
Primary Sponsor
|
| Name |
Optimus Pharma Pvt Ltd |
| Address |
Plot No 73/B 73/B/2 EPIP
Pashamylaram (Village)
Patancheru (Mandal)
Sangareddy (District)
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A V Subba Reddy |
Actimus Biosciences Pvt Ltd |
Ground Floor
Clinic
D-2
D-block
Autonagar
Visakhapatnam
ANDHRA PRADESH |
0891-2750977
subbareddy@actimusbio.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VISAKHA INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AMICAR® (aminocaproic acid) Tablets 1000 mg |
AMICAR® (aminocaproic acid) Tablets 1000 mg Marketed by Clover Pharmaceuticals Corp. Marietta GA 30062 |
| Intervention |
Aminocaproic acid Tablets 1000 mg |
Aminocaproic acid Tablets 1000 mg of Optimus Pharma Private Limited |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Volunteers were being informed
for screening and study participation. The selected healthy volunteers after
screening will be informed to visit the facility for informed consent process.
The interested volunteers who are
willing to participate in the study will be informed to report to the facility.
Medical examination, vitals, breath alcohol analysis and urine drug screening
will be performed for the volunteers who reports for the check-in process.
Inclusion and exclusion criteria
will be evaluated and the volunteers will be recruited into the study by the
investigator for Period-I. After completion of check-in of Period-I subjects
will be provided pre-dose dinner and allowed to rest.
On dosing day subjects will be checked for vitals
and cannulation will be performed. Dosing will be given to the subjects
appropriately. Blood sample will be collected from subjects as per time points
mentioned in Protocol.
Vitals will be measured at
specific time as provided in Protocol. Meals (Lunch, Snacks and dinner) will be
provided as per Protocol. Subjects will be in-house till completion of samples
and will be checked out after medical examination and vitals after collection
of last blood sample in Period-I.
The same process for Period-II
will be carried out from check-in to check-out and a post study sample will be
collected along with last study sample. If any abnormality observed in post
study sample, subject will be followed up till resolution or declared as lost
to follow up.
The test product will be
considered as bioequivalent to the reference product if the 90% CI (Confidence
interval) for the geometric least square mean ratios of ln-transformed
parameters Cmax, AUC0-t and AUC0-inf of Aminocaproic acid falls within the
acceptance range of 80.00-125.00%. |