Kapidex (Dexlansoprazole) - Summary

KAPIDEX SUMMARY

KAPIDEX (dexlansoprazole) in delayed release capsules is a compound that inhibits gastric acid secretion.

Healing of Erosive Esophagitis

KAPIDEX is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.

Maintenance of Healed Erosive Esophagitis

KAPIDEX is indicated to maintain healing of EE for up to 6 months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease

KAPIDEX is indicated for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.

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NEWS HIGHLIGHTS

Published Studies Related to Kapidex (Dexlansoprazole)

Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. [2009.09.04]
SUMMARY Background Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole. Aim To assess safety of dexlansoprazole MR in phase 3 clinical trials Methods Data from 4270 patients receiving dexlansoprazole MR 30 mg (n=455), 60 mg (n=2311), or 90 mg (n=1864); lansoprazole 30 mg (n=1363); or placebo (n=896) in 6 randomized controlled trials and a 12-month safety study were pooled...

Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel Dual Delayed Release formulation of a proton pump inhibitor--evidence for dosing flexibility. [2009.04.15]
BACKGROUND: Dexlansoprazole MR is a proton pump inhibitor with a Dual Delayed Release (DDR) formulation designed to prolong the dexlansoprazole plasma concentration-time profile. The presence of food or time of dosing relative to food may affect dexlansoprazole absorption. AIMS: To evaluate the effect of food on the pharmacokinetics (PK) and pharmacodynamics (PD) of dexlansoprazole following oral administration of dexlansoprazole MR... CONCLUSION: Dexlansoprazole MR can be administered without regard to food or the timing of food in most patients.

Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagitis. [2009.04.01]
BACKGROUND: Dexlansoprazole MR heals all grades of erosive oesophagitis (EO). AIM: To assess efficacy and safety of dexlansoprazole MR in maintaining healed EO and heartburn relief... CONCLUSIONS: Dexlansoprazole MR effectively maintained EO healing and symptom relief; most patients were heartburn-free for >90% of days. Both doses were well tolerated.

Effects of dexlansoprazole MR, a novel dual delayed release formulation of a proton pump inhibitor, on plasma gastrin levels in healthy subjects. [2009.04]
Dexlansoprazole MR is a modified release formulation of a proton pump inhibitor being developed for the treatment of acid-related disorders. The purpose of this study is to characterize the plasma gastrin (PG) profile associated with administration of dexlansoprazole MR... In this study, dexlansoprazole MR administration results in moderate increases in PG, similar to lansoprazole, which return to baseline levels within 7 days post dosing.

Drug Interaction Studies with Dexlansoprazole Modified Release (TAK-390MR), a Proton Pump Inhibitor with a Dual Delayed-Release Formulation : Results of Four Randomized, Double-Blind, Crossover, Placebo-Controlled, Single-Centre Studies. [2009]
BACKGROUND AND OBJECTIVE: Most proton pump inhibitors are extensively metabolized by cytochrome P450 (CYP) isoenzymes, as are many other drugs, giving rise to potential drug-drug interactions. Dexlansoprazole modified release (MR) [TAK-390MR] is a modified-release formulation of dexlansoprazole (TAK-390), an enantiomer of lansoprazole, which employs an innovative Dual Delayed Releasetrade mark technology designed to prolong the plasma dexlansoprazole concentration-time profile following once-daily oral administration. As with lansoprazole, dexlansoprazole is metabolized mainly by CYP3A and CYP2C19. Based on in vitro studies, dexlansoprazole has the potential to inhibit activity of these isoenzymes and also may induce human hepatic CYP1A and CYP2C9 activity. To determine whether dexlansoprazole has an effect on these isoenzymes in vivo, drug interaction studies with dexlansoprazole MR were conducted... CONCLUSIONS: Coadministration of dexlansoprazole MR with diazepam, phenytoin or theophylline did not affect the pharmacokinetics of these drugs, and therefore is unlikely to alter the pharmacokinetic profile of other drugs metabolized by CYP2C19, CYP2C9, CYP1A2 and perhaps CYP3A. Additionally, dexlansoprazole MR coadministered with warfarin did not affect the pharmacokinetics of the warfarin enantiomers and had no effect on the anticoagulant activity of warfarin. Dexlansoprazole MR was well tolerated in these trials of healthy subjects.

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Clinical Trials Related to Kapidex (Dexlansoprazole)

Efficacy of Dexlansoprazole MR on Heartburn Control in Subjects Previously Receiving Twice Daily Proton Pump Inhibitor Therapy [Recruiting]
The purpose of this study is to determine the efficacy of dexlansoprazole MR in subjects with gastroesophageal reflux disease who are currently well-controlled on twice daily proton pump inhibitors.

A Study of the Effects of Multiple Doses of Lansoprazole, Dexlansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Subjects [Not yet recruiting]
The purpose of this study is to assess the potential for lansoprazole, dexlansoprazole, omeprazole or esomeprazole to affect the steady state pharmacokinetics and pharmacodynamics of clopidogrel, and to asses the safety of multiple doses of clopidogrel in combination with lansoprazole, dexlansoprazole, omeprazole or esomeprazole.

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