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drugset / Trial / NCT04261166

A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract

NCT04261166 ↗

Phase 1 Completed 76 enrolled Breath of Life International Pharma Ltd
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2019-07-24
Primary completion
2022-10-24
Completion
2022-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject CBD Unknown 0.6 mg Subcutaneous
Subject CBD Unknown 0.6 mg Subcutaneous
Subject CBD Unknown 3.1 mg Subcutaneous
Subject CBD Unknown 30 mg Subcutaneous
Subject CBD Unknown 34.8 mg Subcutaneous
Subject CBD Unknown 36.6 mg Subcutaneous
Subject CBD Unknown 40 mg Subcutaneous
Subject CBD Unknown 40 mg Subcutaneous
Subject CBD Unknown 40 mg Subcutaneous
Subject THC Unknown 1.7 mg Subcutaneous
Subject THC Unknown 1.8 mg Subcutaneous
Subject THC Unknown 2 mg Subcutaneous
Subject THC Unknown 3.1 mg Subcutaneous
Subject THC Unknown 3.1 mg Subcutaneous
Subject THC Unknown 3.1 mg Subcutaneous
Subject THC Unknown 5 mg Subcutaneous

Indications

No indication recorded.