Livasartan (pitavastatin/valsartan) / JW Pharma - LARVOL DELTA

Determination of valsartan and pitavastatin using synchronous spectrofluorimetry and augmented least squares chemometric models: A comparative study with greenness and blueness assessment. (PubMed, Luminescence) - "Besides, the greenness and blueness profiles of the determined samples were also evaluated to assess their environmental impact and analytical practicability. The results demonstrated excellent greenness and blueness scores with AGREE score of 0.7 and BAGI score of 75 posing the proposed method as reliable and sensitive approach for the determination of valsartan and pitavastatin with potential applications in pharmaceutical quality control, bioanalytical studies, and therapeutic drug monitoring."

Clinical • Journal • Cardiovascular • Dyslipidemia • Hypertension

To Evaluate the Safety and PK Characteristics in Healthy Volunteers (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: JW Pharmaceutical

New P1 trial

To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension (clinicaltrials.gov) - P3 | N=155 | Completed | Sponsor: JW Pharmaceutical | Recruiting ➔ Completed

Trial completion • Cardiovascular • Dyslipidemia • Hypertension • Metabolic Disorders

To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: JW Pharmaceutical

New P1 trial

To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension (clinicaltrials.gov) - P3 | N=144 | Recruiting | Sponsor: JW Pharmaceutical

New P3 trial • Dyslipidemia • Hypertension • Metabolic Disorders

Comparative Pharmacokinetics Between a Fixed-Dose Combination of Pitavastatin/Valsartan 4/160 mg and the Corresponding Individual Components Through a Partial Replicated Crossover Design in Healthy Male Subjects. (PubMed, Clin Pharmacol Drug Dev) - "The geometric mean ratios (90%CIs) for area under the concentration-time curve from time 0 to the last measurable time point and C of both drugs were included in the bioequivalence criteria. In conclusion, the FDC of pitavastatin/valsartan 4/160 mg showed pharmacokinetic equivalence with the corresponding individual components."

Clinical • Journal • PK/PD data • Dyslipidemia • Hypertension • Metabolic Disorders

LAMISIII: The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment (clinicaltrials.gov) - P=N/A; N=905; Recruiting; Sponsor: JW Pharmaceutical; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Dec 2020 ➔ Jun 2022

Adverse events • Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Dyslipidemia • Metabolic Disorders • Myocardial Infarction

Evaluation of the Utility of PXB Chimeric Mice for Predicting Human Liver Partitioning of Hepatic Organic Anion-Transporting Peptide Substrates. (PubMed, Drug Metab Dispos) - "Herein, we explored the utility of PXB chimeric mice with humanized liver that are highly repopulated with human hepatocytes to predict human hepatic disposition of OATPs substrates, including rosuvastatin, pravastatin, pitavastatin, valsartan and repaglinide. More importantly, PXB liver-to-plasma Kpuu values were compared with the reported human Kpuu, and a good correlation was observed. PXB mice could be a useful tool to project human liver-to-plasma Kpuu of hepatic uptake transporter substrates."

Journal • Metabolic Disorders

LAMISIII: The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment (clinicaltrials.gov) - P; N=905; Recruiting; Sponsor: JW Pharmaceutical

Adverse events • Clinical • New trial