Suprega CR (pregabalin CR) / Daewon Pharma, GL PharmTech - LARVOL DELTA

Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: a Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. (PubMed, Clin Ther) - P3 | "GLA5PR GLARS-NF1 tablets can be effectively and safely administered to patients with peripheral neuropathic pain. Furthermore, we found that sleep, anxiety, and depression were improved with pain control. Owing to the once-daily administration, treatment effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907."

Clinical • Journal • P3 data • CNS Disorders • Depression • Mood Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry

The Pharmacokinetics of GLA5PR Tablet According to the Renal Function (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: GL Pharm Tech Corporation; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Jun 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Neuralgia • Pain

Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers. (PubMed, Clin Ther) - P1; "The overall pregabalin exposure after multiple administrations of GLA5PR GLARS-NF1 tablets was comparable to that after multiple administrations of the IR capsules. A single administration of the GLA5PR GLARS-NF1 tablet produced lower overall pregabalin exposure than that of the same dose administered in 2 IR capsules taken every 12 h. A high-fat diet significantly increased the bioavailability of the GLA5PR GLARS-NF1 tablet. ClinicalTrials.gov identifiers: NCT01638273 and NCT02326987."

Clinical • Journal • PK/PD data

The Pharmacokinetics of GLA5PR Tablet According to the Renal Function (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: GL Pharm Tech Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open