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Posted On: 05/07/2019 2:14:26 PM
Post# of 15624
Posted by stockfan:
I would pay close attention to the highlighted part and think about the opportunities if OWCP study could show the MGC-ODT superiority over the other.
Study Description
This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.
Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 16 participants
Primary Purpose: Treatment
ClinicalTrials.gov Identifier: NCT03936907
Other Study ID Numbers: OWC-ODP12
Official Title: A Single-Dose, Randomized, Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) With Buccal Sativex®, in Healthy Adult Volunteers
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel (isr), Israel, 6423906
Contact: Nurit Platner, MA 972-3-6974961
Primary Outcome Measures
Pharmacokinetic parameter- Tmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
he amount of time requires for THC, 11-hydroxy-THC and CBD to reach to maximum concentration in serum
Pharmacokinetic parameter -Cmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
Mean highest observed plasma concentration of THC, 11-hydroxy-THC and CBD after dosing.
Pharmacokinetic parameter- AUC0-t (area under the plasma concentration-time curve) determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
Pharmacokinetic parameter- T½ determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
The time required for the concentration of THC, 11-hydroxy-THC and CBD to reach half of its original value
Pharmacokinetic parameter- kel determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
Elimination rate constant K - The rate at which THC, 11-hydroxy-THC and CBD are removed from the body determined by their plasma concentration.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabilityof MGC-ODTand Sativex® ] [ Time Frame: 2 weeks post dosing ]
Safety
I would pay close attention to the highlighted part and think about the opportunities if OWCP study could show the MGC-ODT superiority over the other.
Study Description
This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.
Study Design
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 16 participants
Primary Purpose: Treatment
ClinicalTrials.gov Identifier: NCT03936907
Other Study ID Numbers: OWC-ODP12
Official Title: A Single-Dose, Randomized, Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) With Buccal Sativex®, in Healthy Adult Volunteers
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel (isr), Israel, 6423906
Contact: Nurit Platner, MA 972-3-6974961
Primary Outcome Measures
Pharmacokinetic parameter- Tmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
he amount of time requires for THC, 11-hydroxy-THC and CBD to reach to maximum concentration in serum
Pharmacokinetic parameter -Cmax determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
Mean highest observed plasma concentration of THC, 11-hydroxy-THC and CBD after dosing.
Pharmacokinetic parameter- AUC0-t (area under the plasma concentration-time curve) determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
Pharmacokinetic parameter- T½ determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
The time required for the concentration of THC, 11-hydroxy-THC and CBD to reach half of its original value
Pharmacokinetic parameter- kel determined from plasma concentrations of THC, 11-hydroxy-THC and CBD. [ Time Frame: 24 hours post dosing ]
Elimination rate constant K - The rate at which THC, 11-hydroxy-THC and CBD are removed from the body determined by their plasma concentration.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabilityof MGC-ODTand Sativex® ] [ Time Frame: 2 weeks post dosing ]
Safety
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