Generic drug trial to seek approval for Paliperidone 1 month injection for treatment of Schizophrenia.

Not Applicable

Completed

• Conditions: Health Condition 1: F209- Schizophrenia, unspecified

• Registration Number: CTRI/2019/06/019840
• Lead Sponsor: Tolmar International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-17
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 314

Inclusion Criteria

Eligibility of patients in the study will be based on the following criteria:

1. Able to understand the investigational nature of this study and provide written informed consent prior to participation in the trial.

2. Subjects between 18 and 65 years of age (both inclusive).

3. Subjects having body mass index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive).

4. Subjects diagnosed with schizophrenia as per DSM-IV-TR (or later) criteria.

5. Subjects clinically stabilized on other antipsychotic medications (apart from paliperidone and risperidone) as per Appendix 14.2 of the protocol.

6. Subjects who have tolerated oral or injectable paliperidone and/or risperidone

prior to dosing.

7. Acceptable hematology status:

a. Hemoglobin >= 9 g/dL

b. Absolute neutrophil count (ANC) >= 1500 cells/μL

c. Platelet count >= 100,000 cells/μL

8. Acceptable liver function:

a. Alanine aminotransferase (ALT) <= 2X upper limit of normal (ULN)

b. Aspartate aminotransferase (AST) <= 2X ULN

c. Bilirubin < 1.2 mg/dL

d. Alkaline phosphatase <= 2X ULN

9. Subjects with creatinine clearance >= 80 mL/minute.

10. Female subjects with negative serum pregnancy test at screening.

11. Subjects who agree to use adequate contraception (e.g., hormonal, chemical, double-barrier, or abstinence) while in the study and for 3 months after study participation is discontinued.

12. No history of addiction to any recreational drug or drug dependence or alcohol addiction within 12 months prior to randomization.

13. Must be able to attend regularly scheduled study center appointments and be able to abide by all study requirements.

Exclusion Criteria

1. Hypersensitivity to paliperidone palmitate or risperidone or to any of the excipients of the formulations.

2. Treatment naïve subjects.

3. Subjects who have been administered

a. oral paliperidone or risperidone within 2 weeks prior to randomization

b. injectable risperidone within 3 months prior to randomization

c. injectable paliperidone 1-month formulation within 8 months prior to randomization

d. injectable paliperidone 3-month formulation within 24 months prior to randomization

4. Subjects who are in an acutely agitated or severely psychotic state.

5. Smokers

6. Subjects who have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening.

7. Subjects who have a rating of > 4 (moderately ill) on the CGI-S scale at screening

8. Subjects who need to remain on antipsychotic treatment(s) that are incompatible to co-treatment with paliperidone or risperidone or that may interfere or impede clinically with a single dose of paliperidone.

9. History or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, dementia-related psychosis, Parkinsonâ??s disease or epilepsy/seizures.

10. History or presence of any uncontrolled debilitating systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, etc.).

11. Subjects with congenital long QT syndrome (QTc of > 470 msec for females and > 450 msec for males) or presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within past 12 months.

12. Subjects with history of arrhythmia.

13. Subjects with positive urine screen for drugs of abuse (except for benzodiazepine which is a permissible medication if supported by prescription)

14. Major surgical procedure (including periodontal) within 28 days of IP dosing.

15. Current surgical or other non-healing wounds.

16. Subjects with positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).

17. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study or that could limit adherence to study requirements.

18. Participation in any clinical study within 90 days of IP dosing.

19. Donation and/or loss of >= 350 mL (1 unit) of blood within 90 days of IP dosing.

20. Lactating women.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To establish the single dose bioequivalence of equivalent doses of TEST [PP-PRIS 100 mg (Tolmar)] and RMP [Xeplion 100 mg (Janssen-Cilag International NV)] <br/ ><br> <br/ ><br>Timepoint: Day-1: Pre-dose blood sample (00.00) within 30 minutes prior to dosing, 6 hrs ± 10 minutes Day-2: 24 hrs (±10 minutes),Day-3:48 hours,Day-4:72 hrs(±60 minutes),Day-6:120hrs, Day-8:168hrs,Day-10:216hrs,Day-12:264hrs,Day-14:312hrs,Day-16:360hrs,Day-18:408hrs(±4 hours), Day-25:576hrs,Day-32:744hrs,Day-46:1080hrs,Day-60:1416hrs,Day-74:1752hrs,Day-95:2256hrs,Day-116:2760hrs,Day-137:3264hrs,Day-158:3768hrs (± 2 days) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess safety and tolerability of RMP and TEST in subjects who are exposed to the Investigational Product (IP; either TEST or RMP).Timepoint: Day-1: Pre-dose blood sample (00.00) within 30 minutes prior to dosing, 6 hrs ± 10 minutes Day-2: 24 hrs (±10 minutes),Day-3:48 hours,Day-4:72 hrs(±60 minutes),Day-6:120hrs, Day-8:168hrs,Day-10:216hrs,Day-12:264hrs,Day-14:312hrs,Day-16:360hrs,Day-18:408hrs(±4 hours), Day-25:576hrs,Day-32:744hrs,Day-46:1080hrs,Day-60:1416hrs,Day-74:1752hrs,Day-95:2256hrs,Day-116:2760hrs,Day-137:3264hrs,Day-158:3768hrs (± 2 days) <br/ ><br>