Healthy
Conditions
Brief summary
This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight fasting designed to study the safety and PK of medicated drops and tablet formulation for sublingual administration.
Interventions
DRUGA1
Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops)
DRUGA2
Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop)
DRUGA3
Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop)
DRUGA4
Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops)
DRUGA5
Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop)
DRUGB1
Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet)
DRUGB2
Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet)
DRUGB3
Sublingual tablets. CBD 40 mg (1 tablet)
DRUGB4
Sublingual tablets. CBD 40 mg (1 tablet)
Sponsors
Breath of Life International Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, male or female, between 18 and 45 years of age (inclusive). 2. Body mass index (BMI) between 20-30 kg/m2 (both inclusive) 3. No recent cannabis usage within 30 days from screening 4. Normal rage hepatic functions 5. No electrolytes abnormalities 6. Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges: 1. Body temperature between 35.0 to 37.5 °C 2. Systolic blood pressure, 90 to 150 mmHg\* 3. Diastolic blood pressure, 60 to 90 mmHg\* 4. Pulse rate, 50 to 90 beats per minute\*. 5. \*Blood pressure and pulse rate will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension).
Exclusion criteria
1. Blood donation within 90 days 2. History of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastroenterology, endocrine, immunology, dermatologic, neurologic or psychiatric disorders 3. Subjects with a history of alcohol, drug abuse, chronic cannabis use within 2 years of study 4. Pregnant women 5. Subjects who used any prescription or OTC medication in the past 14 days with the exception of paracetamol or ibuprofen. 6. Sexually active males whose partner is of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP 7. Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. 8. Subjects who had postural drop of \> 20 mmHg in systolic blood pressure at screening 9. Patients with heart failure, 10. Subjects with a history of psychotic state in the past or anxiety disorder, 11. Subjects at age of less than 30 years with a history of psychiatric disease in a first-degree family member 12. Subjects with a history of addiction or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic analysis of Cmax | 0-12 hours post dose |
| Pharmacokinetic analysis of Tlag | 0-12 hours post dose |
| Pharmacokinetic analysis of Tmax | 0-12 hours post dose |
| Pharmacokinetic analysis of AUC(0-t) | 0-12 hours post dose |
| Pharmacokinetic analysis of AUC(0-∞) | 0-12 hours post dose |
| Pharmacokinetic analysis of %AUC extrapolated | 0-12 hours post dose |
| Pharmacokinetic analysis of T1/2 | 0-12 hours post dose |
| Pharmacokinetic analysis of clearance from plasma (Cl/F) | 0-12 hours post dose |
| Pharmacokinetic analysis of ratio of the Volume of distribution based on the terminal phase to the bioavailability (Vz/F) | 0-12 hours post dose |
| Pharmacokinetic analysis of clearance from plasma dose normalized Cmax | 0-12 hours post dose |
| Pharmacokinetic analysis of dose normalized AUC | 0-12 hours post dose |
Countries
Israel
Outcome results
None listed