New 8-k out! https://sec.report/Document/000149
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Posted On: 10/07/2019 9:28:51 AM
New 8-k out!
https://sec.report/Document/0001493152-19-015116/
Item 8.01 Other Events.
OWC Pharmaceutical Research Corp. (“OWC”) announced that, on September 25, 2019, One World Cannabis Ltd., a company organized and existing under the laws of Israel and a wholly-owned subsidiary of OWC received Top Line Results (TLR) of its single-dose, randomized, crossover study to compare the safety, tolerability and pharmacokinetics (PK) of OWC’s Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) vs. buccal Sativex®, in healthy adult volunteers. The study was conducted at the Sourasky Medical Center in Tel Aviv. In this study, participants were administered randomly, either Sativex (5.4 mg THC, 5.0 mg CBD) or OWC-ODT (4.2 mg THC, 5 mg CBD), and then crossed over, with a minimum interval of two weeks. Plasma was collected in the 24 hours following drug administration, at pre-determined time points, and side effects were monitored. The concentrations of THC, CBD and 11-OH-THC were quantified, and their plasma PK determined.
The TLR show that both MGC-ODT and Sativex® administration had comparable mean times of peak concentration, half-life and elimination rates for each of the three analytes (THC, THC metabolite 11-hydroxy-THC and CBD). The results indicated dose-related comparability of both products in rate of absorption and bioavailability. The incidence of treatment related adverse events (AEs) were similar between the treatments.
The most common treatment related AEs were hunger (reported in 25% of subjects treated with MGC-ODT), thirst (reported in 18.75% and 6.25% of subjects treated with MGC-ODT and Sativex®, respectively), dizziness (reported in 18.75% and 18.75% of subjects treated with MGC-ODT and Sativex®, respectively), dysgeusia (reported in 12.5% and 25% of subjects treated with MGC-ODT and Sativex®, respectively). Administration of MGC-ODT was judged to be well tolerated and no unexpected safety signals were observed.
Top Line Results Conclusions: OWC- Orally Disintegrating Tablet is safe to use and appears to have similar PK and bioavailability as Sativex® . Therefore, OWC intends to apply to the Israel Ministry of Health to obtain necessary approvals to market its Medical Grade Cannabis - Orally Disintegrating Tablets in Israel.
https://sec.report/Document/0001493152-19-015116/
Item 8.01 Other Events.
OWC Pharmaceutical Research Corp. (“OWC”) announced that, on September 25, 2019, One World Cannabis Ltd., a company organized and existing under the laws of Israel and a wholly-owned subsidiary of OWC received Top Line Results (TLR) of its single-dose, randomized, crossover study to compare the safety, tolerability and pharmacokinetics (PK) of OWC’s Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) vs. buccal Sativex®, in healthy adult volunteers. The study was conducted at the Sourasky Medical Center in Tel Aviv. In this study, participants were administered randomly, either Sativex (5.4 mg THC, 5.0 mg CBD) or OWC-ODT (4.2 mg THC, 5 mg CBD), and then crossed over, with a minimum interval of two weeks. Plasma was collected in the 24 hours following drug administration, at pre-determined time points, and side effects were monitored. The concentrations of THC, CBD and 11-OH-THC were quantified, and their plasma PK determined.
The TLR show that both MGC-ODT and Sativex® administration had comparable mean times of peak concentration, half-life and elimination rates for each of the three analytes (THC, THC metabolite 11-hydroxy-THC and CBD). The results indicated dose-related comparability of both products in rate of absorption and bioavailability. The incidence of treatment related adverse events (AEs) were similar between the treatments.
The most common treatment related AEs were hunger (reported in 25% of subjects treated with MGC-ODT), thirst (reported in 18.75% and 6.25% of subjects treated with MGC-ODT and Sativex®, respectively), dizziness (reported in 18.75% and 18.75% of subjects treated with MGC-ODT and Sativex®, respectively), dysgeusia (reported in 12.5% and 25% of subjects treated with MGC-ODT and Sativex®, respectively). Administration of MGC-ODT was judged to be well tolerated and no unexpected safety signals were observed.
Top Line Results Conclusions: OWC- Orally Disintegrating Tablet is safe to use and appears to have similar PK and bioavailability as Sativex® . Therefore, OWC intends to apply to the Israel Ministry of Health to obtain necessary approvals to market its Medical Grade Cannabis - Orally Disintegrating Tablets in Israel.
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