Evaluation of Safety, Rate and Extent of... — Clinical Trial Details

Participants

Ages

21 – 50

Sexes

male

BMI

18.5 - 30

Psychosis History

Inclusion Criteria

Age 21-50 years.
Body-mass index 18.5 to 30.0 kg/m2 inclusive. (Minimum of 50 kg weight for males and 45 kg for females).
Subject is available for the whole study period and gave written informed consent.
Normal physical examination or being assessed as clinically non-significant by the attending physician.
Normal neurological, cardiovascular, cerebrovascular, gastrointestinal and respiratory systems.
Normal Vital Signs. Normal Electrocardiogram (ECG). Subjects refraining from alcohol use, other study medication and drugs.
Lab test inclusion criteria: On Screening Chemistry, Hematology and Urine laboratory screening results within the normal range, or being assessed as clinically non-significant by the attending physician.
Normal Liver and kidney function test.

Exclusion Criteria

Lab test exclusion criteria: On screening
1. Positive serology test.
2. Chemistry, Haematology and Urine laboratory screening results not within the normal range, or being assessed as clinically significant by the attending physician.
3. Abnormal Liver and kidney function test.
4. Positive hCG for female subjects.
On Admission:
1. Intake of caffeine, xanthene, or CO2-containing beverages within 24 hours of drug administration.
2. Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of drug administration.
3. Ingestion of any supplements like vitamins or herbal products within 7 days prior to each drug administration study.
4. Clinically significant illness 4 weeks before study Period I.
5. Exhausting physical exercise in the last 24 hours or any recent significant change in dietary or exercise habits.
6. Abnormal vital signs and being assessed as clinically significant.
7. Vomiting, diarrhea on admission.
8. Subjects with concurrent medication must stop 14 days before drug administration and during study period especially warfarin, aspirin, NSAIDs, levodopa, antipsychotics, fibrates, ciclosporin, fusidic acid.
9. Participation in another bioequivalence study and/or clinical trials within 80 days prior to the start of this study Period.
10. Regular consumption of drugs affecting the study drug (e.g., barbiturates, carbamazepine, phenytoin, amphetamine, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, methadone) within two weeks before study initiation.
11. Taking strong CYP3A4 inhibitors or inducers within 4 weeks prior to study.
12. Taking monoamine oxidase inhibitors.
13. Taking SSRI/SNRI medications.
14. Taking UDP-glucuronosyl transferase enzyme modulators medication.
Pre-dose:
1. Pre-dosing blood pressure less than 110/70 mmHg.
2. Pre-dosing heart rate less than 70 beats per minute.

Company

Product

Legal

Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate (Psilocin-1)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Psilocin mucate

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators