Cargando…

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects

BACKGROUND: A formal single ascending and multiple dose pharmacokinetic (PK) trial of cannabidiol (CBD) oral solution was required to determine the safety and tolerability of CBD, the maximum tolerated dose, and to examine the effect of food on CBD PK parameters. OBJECTIVE: This trial assessed the s...

Descripción completa

Detalles Bibliográficos
Autores principales:	Taylor, Lesley, Gidal, Barry, Blakey, Graham, Tayo, Bola, Morrison, Gilmour
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2018
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6223703/ https://www.ncbi.nlm.nih.gov/pubmed/30374683 http://dx.doi.org/10.1007/s40263-018-0578-5

Ejemplares similares

A Phase I, Open-Label, Parallel-Group, Single-Dose Trial of the Pharmacokinetics, Safety, and Tolerability of Cannabidiol in Subjects with Mild to Severe Renal Impairment
por: Tayo, Bola, et al.
Publicado: (2019)

A Phase 1, Open‐Label, Parallel‐Group, Single‐Dose Trial of the Pharmacokinetics and Safety of Cannabidiol (CBD) in Subjects With Mild to Severe Hepatic Impairment
por: Taylor, Lesley, et al.
Publicado: (2019)

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects
por: Crockett, Julie, et al.
Publicado: (2020)

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study
por: Li, Haiyan, et al.
Publicado: (2020)

A Phase 1, Open‐Label, Pharmacokinetic Trial to Investigate Possible Drug‐Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects
por: Morrison, Gilmour, et al.
Publicado: (2019)

Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects
por: Sheng, Lei, et al.
Publicado: (2021)

Randomized, Double-Blind, Placebo-Controlled Studies of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Eravacycline
por: Newman, Joseph V., et al.
Publicado: (2018)

A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects
por: Brager, Jenna, et al.
Publicado: (2022)

A Phase 2, Double‐Blind, Placebo‐Controlled Trial to Investigate Potential Drug‐Drug Interactions Between Cannabidiol and Clobazam
por: VanLandingham, Kevan E., et al.
Publicado: (2020)

Safety, tolerability, and pharmacokinetics of oral baicalein tablets in healthy Chinese subjects: A single‐center, randomized, double‐blind, placebo‐controlled multiple‐ascending‐dose study
por: Li, Lijun, et al.
Publicado: (2021)

A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug–Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy
por: Ben-Menachem, Elinor, et al.
Publicado: (2020)

A Phase 1 Open‐Label, Fixed‐Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects
por: Thai, Ching, et al.
Publicado: (2021)

Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
por: Bruinenberg, Paul, et al.
Publicado: (2022)

Pharmacokinetics, Tolerability and Pharmacogenetics of DA-8031 After Multiple Ascending Doses in Healthy Male Subjects
por: Hwang, Sejung, et al.
Publicado: (2021)

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Sotagliflozin After Multiple Ascending Doses in Chinese Healthy Subjects
por: He, Xuemei, et al.
Publicado: (2022)

A Randomized, Double‐Blind, Placebo‐Controlled, First‐Time‐in‐Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects
por: Han, Kelong, et al.
Publicado: (2019)

PSUN305 A Double-Blind, Placebo-Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Obese or Overweight Subjects with Co-morbidities
por: Shin, Wonjung, et al.
Publicado: (2022)

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Tolerance, Pharmacokinetics of Jaktinib, a New Selective Janus Kinase Inhibitor in Healthy Chinese Volunteers
por: Liu, Jingrui, et al.
Publicado: (2020)

Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects
por: Tiffany, Courtney, et al.
Publicado: (2022)

Clinical implications of trials investigating drug‐drug interactions between cannabidiol and enzyme inducers or inhibitors or common antiseizure drugs
por: Patsalos, Philip N., et al.
Publicado: (2020)

A Phase 1, Randomised, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Cannabidiol in Fed Healthy Volunteers
por: Perkins, Daniel, et al.
Publicado: (2020)

Pharmacokinetics of ASP4345 from Single Ascending-Dose and Multiple Ascending-Dose Phase I Studies
por: Desai, Amit, et al.
Publicado: (2020)

Pharmacokinetics of escalating single‐dose administration of cannabidiol to cats
por: Rozental, Aaron J., et al.
Publicado: (2022)

The randomized, single‐ and multiple‐ ascending dose studies of the safety, tolerability, pharmacokinetics of CSPCHA115 in healthy Chinese subjects
por: Jing, Shan, et al.
Publicado: (2022)

1421. IV Brincidofovir (BCV): Pharmacokinetics (PK) and Safety of Multiple Ascending Doses (MAD) in Healthy Subjects
por: Naderer, Odin, et al.
Publicado: (2018)

Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome
por: Devinsky, Orrin, et al.
Publicado: (2018)

Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, and Pharmacokinetics of the Polymyxin Derivative SPR206
por: Bruss, Jon, et al.
Publicado: (2021)

Safety, tolerability, and pharmacokinetics of a single ascending subcutaneous dose of GSK3772847 in healthy participants
por: Pefani, Eleni, et al.
Publicado: (2023)

Safety, Tolerability, Pharmacokinetics and Initial Pharmacodynamics of a Subcommissural Organ-Spondin-Derived Peptide: A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose First-in-Human Study
por: Bourdès, Valérie, et al.
Publicado: (2022)

Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy
por: Wheless, James W., et al.
Publicado: (2019)

Safety and Pharmacokinetics of High‐Dose TAS‐303 in Healthy Japanese Volunteers: A Single‐Center, Single‐Blind, Randomized, Placebo‐Controlled, Parallel‐Group, Multiple‐Ascending‐Dose Study
por: Hanada, Ryuzo
Publicado: (2020)

The therapeutic potential of purified cannabidiol
por: O’Sullivan, Saoirse Elizabeth, et al.
Publicado: (2023)

Safety, tolerability and efficacy of intra-articular Progenza in knee osteoarthritis: a randomized double-blind placebo-controlled single ascending dose study
por: Kuah, D., et al.
Publicado: (2018)

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral NLRP3 Inflammasome Inhibitor ZYIL1: First‐in‐Human Phase 1 Studies (Single Ascending Dose and Multiple Ascending Dose)
por: Parmar, Deven V., et al.
Publicado: (2022)

Safety, Tolerability and Pharmacokinetics of Vidofludimus calcium (IMU-838) After Single and Multiple Ascending Oral Doses in Healthy Male Subjects
por: Muehler, Andreas, et al.
Publicado: (2020)

Safety and tolerability of high-dose ulinastatin after 2-hour intravenous infusion in adult healthy Chinese volunteers: A randomized, double-blind, placebo-controlled, ascending-dose study
por: Chen, Qian, et al.
Publicado: (2017)

A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel spiroindolone KAE609, to assess the safety, tolerability and pharmacokinetics in healthy adult volunteers
por: Leong, Joel, et al.
Publicado: (2014)

A first-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending oral dose study to assess the safety, tolerability, and pharmacokinetics of BZF961 with and without ritonavir in healthy adult volunteers
por: Youngberg, Stephen, et al.
Publicado: (2018)

A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects
por: Fossler, Michael J., et al.
Publicado: (2020)

Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC‐302 in Healthy Participants: Randomized, Double‐Blind, Placebo‐Controlled, Single‐Dose and Multiple‐Dose Studies
por: Sesoko, Shogo, et al.
Publicado: (2020)

Cannot write session to /tmp/vufind_sessions/sess_l0kfgnsslvnat9vp33bqs9ir0v