An open label study in two parallel groups, each receiving in a randomized, two period, cross-over design two single doses of Risperdal® Consta®, to explore the comparative bioavailability of two different batches of Risperdal® Consta® and the intra subject variability of one Risperdal® Consta® batch after intramuscular administration in healthy volunteers

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

* Healthy male or non-pregnant, non-breastfeeding female subject, aged between 18 and 64 years of age (inclusive) with a minimum weight of 50 kg and BMI *18 kg/m2 and * 30 kg/m2.
* Not a poor metabolizer for CYP2D6.
* No signs of orthostatic hypotension.
* Demonstrated tolerability to oral risperidone in the extended screening phase.

Exclusion Criteria

1. Subject shows clinically significant abnormalities in physical examination, vital signs, 12-lead ECG, or clinical laboratory parameters according to the Investigator*s judgment.
2. Subject who is a poor metabolizer for CYP2D6.
3. Subject has a medical history of allergies including hypersensitivity or idiosyncratic reaction against drug or any of its ingredients or any drug substances with similar activity or clinically significant allergies, incl. asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
4. Subject has a medical history or presence of clinically significant abnormalities of hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, cardiovascular system, cancer or has a history of cancer.
5. Subject has a QTc (Bazett and Fridericia) prolongation greater than or equal to 440 ms, or has significant electrocardiogram (ECG) abnormalities.
6. Subject has a known history or presence of stroke or cardiovascular disease, including heart failure, hypertension, hypotension, cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention, coronary-artery bypass grafting, unstable angina, or thrombotic thrombocytopenic purpura.
7. Subject has known history or presence of involuntary movements of the tongue, mouth, face, or limbs.
8. Subject has a known history or presence of schizophrenia, manic or bipolar disorder, dementia, parkinsonism, any disorder involving falls or postural instability, Neuroleptic Malignant Syndrome (NMS), developmental disorder, autism, mental retardation, tic or movement disorder, or suicidal thoughts.
9. Subject has a history of seizures or other conditions that potentially lower the seizure threshold.
10. Subject has diabetes mellitus or impaired glucose tolerance.
11. Subject has presence of excessive hair, bruises, scars, or tattoo around the injection area (gluteal muscle).
12. Subject smokes more than 5 cigarettes or equivalents per day as per history taken.
13. Subject is unwilling or unable to refrain from smoking while in the clinical research unit.
14. Subject shows positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus (HIV) I/II antibodies and antigen tests.
15. Subject has a supine SBP < 90mmHg or supine SBP > 140mmHg, or supine DBP < 55mmHg or supine DBP > 90mmHg, or Pulse rate > 100 per/min.
16. Subject has signs of orthostatic hypotension.
17. Subject scored *yes* on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or *yes* on any item of the Suicidal Behavior section, except for the *Non-Suicidal Self-Injurious Behavior* (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years).
18. Subject has used any prescription drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days prior to Day 1 of Phase I until the last PK sample in Phase II, period 2.
19. Subject participated in a previous clinical trial with administered IMP within 30 days prior to Day 1 of the oral dosing period.
20. Subject is a heavy alcohol consumer (alcohol > 23 units/week for males and > 13 units/week for females) or cannot stop drinking while in the clinical research unit.
21. Subject lost a volume of blood, including through blood donation, of more tha

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PK measurements includes:AUC0-t, AUC0-infinite, Cmax, Tmax, Cmax and Tmax<br /><br>initial burst phase (timeframe 0-24h), Tlag, and terminal t1/2,.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety / tolerability parameters iclude: (S)AEs, hematology, clinical<br /><br>chemistry, urinalysis, vital signs (supine and standing systolic and diastolic<br /><br>blood pressure and heart rate), electrocardiogram (ECG), local tolerability at<br /><br>the injection site, C-SSRS, ESRS, and prolactin levels.</p><br>