| CTRI Number |
CTRI/2022/04/041819 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence Study of Cariprazine Capsules 1.5 mg |
|
Scientific Title of Study
|
An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Crossover, Single Dose Oral Bioequivalence Study of Cariprazine Capsules 1.5 mg (Test) of Optimus Pharma Limited, India and CARISPECTM (Cariprazine) Capsules 1.5 mg (Reference) of SUN Pharmaceutical Industries Ltd., in Healthy Adult Human Subjects under Fasting Condition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CS21181 Version No.: 00 Date: 31 Jan 2022 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Daniel |
| Designation |
Deputy Manager- Bioclinical Research |
| Affiliation |
Admerus Biosciences Private Limited |
| Address |
Survey No. 480, Basuragadi Village, Gowdavalli Grampanchayat, Medchal Mandal and District Hyderabad-501401 Telangana, India
Hyderabad
TELANGANA
501401
India |
| Phone |
04067927777 |
| Fax |
|
| Email |
Daniel.s@admerus.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Daniel |
| Designation |
Deputy Manager- Bioclinical Research |
| Affiliation |
Admerus Biosciences Private Limited |
| Address |
Survey No. 480, Basuragadi Village, Gowdavalli Grampanchayat, Medchal Mandal and District Hyderabad-501401 Telangana, India
Hyderabad
TELANGANA
501401
India |
| Phone |
04067927777 |
| Fax |
|
| Email |
Daniel.s@admerus.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinayak Sargar |
| Designation |
Assistant Manager- Medical Affairs |
| Affiliation |
Optimus Pharma Pvt. Ltd. |
| Address |
Optimus Pharma Pvt. Ltd.
2nd Floor, Sy No. 37A and 37P, Plot No.6P, Signature Towers, Kothaguda, Kondapur,
Hyderabad
Hyderabad
TELANGANA
500084.
India |
| Phone |
8007207400 |
| Fax |
|
| Email |
vinayak@optimuspharma.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Optimus Pharma Pvt Ltd |
| Address |
Optimus Pharma Pvt. Ltd.
2nd Floor, Sy No. 37A and 37P,
Plot No.6P, Signature Towers,
Kothaguda, Kondapur,
Hyderabad 500084. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Daniel |
Admerus Biosciences Private Limited |
Survey No. 480, Basuragadi Village,
Gowdavalli Grampanchayat,
Medchal Mandal and District
Hyderabad 501 401, Telangana, India
Ph: 04067927777
Hyderabad
TELANGANA |
04067927777
Daniel.s@admerus.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vasavi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adult Human Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cariprazine Capsules 1.5 mg |
Cariprazine Capsules 1.5 mg
Manufactured by: Optimus Pharma Limited, India |
| Comparator Agent |
Carispec (Cariprazine) Capsules 1.5 mg |
Carispec (Cariprazine) Capsules 1.5 mg
Manufactured by: SUN Pharmaceutical Industries Ltd. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers meeting all the following inclusion criteria will be considered for enrolment in the study:
1. Healthy human subjects aged between 18 years and 45 years (both inclusive).
2. Having a Body Mass Index (BMI) between 18.50 and 24.99 kg/m2 (both inclusive).
3. All volunteers must be judged by the Principal or Co-investigator or physician as normal and have no abnormal (clinically significant) findings during screening (medical history and examination, vitals, laboratory evaluations and ECG recording) within 28 days and chest X-Ray evaluation within 12 months prior to period-I dosing of study drug.
4. Normal values in the assessment of depression using Depression Assessment Scale during each period check-in.
5. Subjects are non-smokers and non-alcoholics.
6. Subjects willing to adhere to protocol requirements and provide written informed consent.
7. Females who are
a. Childbearing 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 devices (IUD) or abstinence: or
b. Post-menopausal for at least 1 year, or
c. Surgically sterile (has undergone bilateral tubal ligation, bilateral; oophorectomy or hysterectomy).
|
|
| ExclusionCriteria |
| Details |
Volunteers will be excluded from participation in the study, if they meet any one of the
following exclusion criteria
1. Volunteer having known history of hypersensitivity to Cariprazine or to any component of the formulation.
2. History or evidence of Depression, Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders.
3. History of Irritable bowel syndrome with pain/discomfort as predominant symptom.
4. History of constipation or chronic constipation and using related drugs.
5. History or suspected with Intestinal obstruction due to tumor, hernia etc, as bowel obstruction disorder.
6. History or evidence of COVID-19 during last 1 month
7. History of loose stools in past 10 days.
8. Any disease or condition which might compromise the hematopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, genital or any other body system.
9. Participation in any clinical research study or any bioavailability/bioequivalence study within 90 days prior to first dosing of the present study.
10. Blood donation within 90 days prior to first dosing of the present study.
11. History of difficulty in donating blood or difficulty in accessibility of veins.
12. History or evidence of drug dependence.
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rate and extent of absorption of Cariprazine Capsules 1.5 mg of Optimus Pharma Limited, India and CARISPECTM (Cariprazine) Capsules 1.5 mg of SUN Pharmaceutical Industries Ltd., in healthy, adult, human subjects under fasting Condition. |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor the subject’s safety and tolerability of single dose oral dose of
investigational products (IPs). |
NIL |
|
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Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
An open label, balanced, randomized, two treatment, two sequence, twoperiod, crossover, single dose, oral bioequivalence study in healthy adult human subjects under fasting condition. The active ingredient of Cariprazine is cariprazine HCl, an atypical antipsychotic. The mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding profiles similar to the parent drug. |