A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 As Compared to RLD2401 in Chronic Low-Back Pain Patients

A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as compared to RLD2401 in Chronic Low-Back Pain Patients

Start Date20 Nov 2024

Sponsor / Collaborator

Hanmi Pharmaceutical Co., Ltd.

KCT0000701 / CompletedPhase 1

Randomized, Open, 2-way cross over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HCP1004 and VIMOVO 500/20mg in Healthy Korean Male

Start Date01 Nov 2012

Sponsor / Collaborator-

100 Clinical Results associated with Esomeprazole Strontium/Naproxen

100 Translational Medicine associated with Esomeprazole Strontium/Naproxen

100 Patents (Medical) associated with Esomeprazole Strontium/Naproxen

Literatures (Medical) associated with Esomeprazole Strontium/Naproxen

Drug Design, Development and TherapyQ3 · MEDICINE

Comparison of the pharmacokinetics and tolerability of HCP1004 (a fixed-dose combination of naproxen and esomeprazole strontium) and VIMOVO® (a marketed fixed-dose combination of naproxen and esomeprazole magnesium) in healthy volunteers

Q3 · MEDICINE

ArticleOA

Author: Lim, Kyoung Soo ; Yu, Kyung-Sang ; Choi, YoonJung ; Han, HyeKyung ; Shin, Dongseong

BACKGROUNDHCP1004 is a newly developed fixed-dose combination of naproxen (500 mg) and esomeprazole strontium (20 mg) that is used in the treatment of rheumatic diseases and can reduce the risk of nonsteroidal anti-inflammatory drug-associated ulcers. The aim of this study was to evaluate the pharmacokinetics (PK) and safety of HCP1004 compared to VIMOVO(®) (a marketed fixed-dose combination of naproxen and esomeprazole magnesium).SUBJECTS AND METHODSAn open-label, randomized, two-treatment, two-sequence crossover, single-dose clinical study was conducted in 70 healthy volunteers. In each period, a reference (VIMOVO(®)) or test (HCP1004) drug was administered orally, and serial blood samples for PK analysis were collected up to 72 hours after dosing. To evaluate the PK profiles, the maximum plasma concentration (Cmax) and the area under the concentration-time curve from 0 to the last measurable time (AUC0-t) were estimated using a noncompartmental method. Safety profiles were evaluated throughout the study.RESULTSSixty-six of the 70 subjects completed the study. The Cmax (mean ± standard deviation) and AUC0-t (mean ± standard deviation) for naproxen in HCP1004 were 61.67 ± 15.16 µg/mL and 1,206.52 ± 166.46 h · µg/mL, respectively; in VIMOVO(®); these values were 61.85 ± 14.54 µg/mL and 1,211.44 ± 170.01 h · µg/mL, respectively. The Cmax and AUC0-t for esomeprazole in HCP1004 were 658.21 ± 510.91 ng/mL and 1,109.11 ± 1,111.59 h · ng/mL, respectively; for VIMOVO(®), these values were 595.09 ± 364.23 ng/mL and 1,015.12 ± 952.98 h · ng/mL, respectively. The geometric mean ratios and 90% confidence intervals (CIs) (HCP1004 to VIMOVO(®)) of the Cmax and AUC0-t of naproxen were 0.99 (0.94-1.06) and 1.00 (0.98-1.01), respectively. For esomeprazole, the geometric mean ratios (90% CI) for the Cmax and AUC0-t were 0.99 (0.82-1.18) and 1.04 (0.91-1.18), respectively. The overall results of the safety assessment showed no clinically significant issues for either treatment.CONCLUSIONThe PK of HCP1004 500/20 mg was comparable to that of VIMOVO(®) 500/20 mg for both naproxen and esomeprazole after a single oral dose. Both drugs were well-tolerated without any safety issues.

PLOS ONEQ3 · CROSS-FIELD

A comparative study of the efficacy of NAXOZOL compared to celecoxib in patients with osteoarthritis

Q3 · CROSS-FIELD

ArticleOA

Author: Lee, Sahnghoon ; Moon, Seong-Hwan ; Kim, Ho-Joong ; Shin, Sang-Jin ; Park, Moon Soo ; Kang, Chang-Nam ; Lee, Woo-Suk ; Kim, Jin Hwan

OBJECTIVESelective cyclooxygenase-2 inhibitors (celecoxib) can minimize the gastrointestinal complications related to non-steroidal anti-inflammatory drug (NSAID) use. NAXOZOL is a new combination formulation designed to provide sequential delivery of a non-enteric-coated, immediate-release esomeprazole strontium tetrahydrate 20 mg mantle followed by an enteric-coated naproxen 500 mg core. However, there have been no studies comparing NAXOZOL to celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. This study was undertaken to compare the effects of NAXOZOL and celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis.METHODSThe randomized enrolled patients were divided into two treatment groups: a NAXOZOL group and a celecoxib group. All participants received treatments (NAXOZOL, 500/20 mg (naproxen 500 mg, esomeprazole strontium tetrahydrate 20 mg) twice per day versus celecoxib, 200 mg daily) on a 1:1 allocation basis for 12 weeks. The primary outcome was the Leeds Dyspepsia Questionnaire (LDQ) score used for non-inferiority testing. Secondary outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS) score, Visual Analogue Scale (VAS) score, European Quality of Life-5 dimensions (EQ-5D) scale and the EQ-5D Visual Analogue Scale (EQ VAS). Other outcome measures included the use of supplementary or rescue drugs, and the incidence of adverse events.RESULTSThe baseline-adjusted LDQ scores immediately after 12 weeks of treatment in NAXOZOL group were not inferior to those in celecoxib group. The overall change in the baseline-adjusted GSRS score, VAS score, EQ-5D, and EQ VAS was not different between the two groups. The usage of supplementary drugs and the drug-related incidence of adverse events were not different. However, the days to use rescue drug were longer in celecoxib group than in NAXOZOL group.CONCLUSIONNAXOZOL was not inferior to celecoxib in protecting the gastrointestinal tract and providing pain relief in patients with osteoarthritis.

100 Deals associated with Esomeprazole Strontium/Naproxen

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	KR	Hanmi Pharmaceutical Co., Ltd.	21 Aug 2013
Osteoarthritis	KR	Hanmi Pharmaceutical Co., Ltd.	21 Aug 2013
Rheumatoid Arthritis	KR	Hanmi Pharmaceutical Co., Ltd.	21 Aug 2013

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Low Back Pain	Phase 3	KR	Hanmi Pharmaceutical Co., Ltd.	20 Nov 2024

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