Newly formulated GROWJECT

bioequivalence human GH injection site pain phosphate buffer

Journal

Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology
ISSN: 0918-5739
Titre abrégé: Clin Pediatr Endocrinol
Pays: Japan
ID NLM: 9433330

Informations de publication

Date de publication:
2021
Historique:
received: 25 05 2020
accepted: 04 09 2020
entrez: 15 1 2021
pubmed: 16 1 2021
medline: 16 1 2021
Statut: ppublish

Résumé

Daily treatment with subcutaneous injections of recombinant human GH can be physically and emotionally stressful for children and their caregivers owing to the pain caused by injection. In this study, 52 healthy male subjects were randomized to investigate the bioequivalence and compare the safety and injection-associated pain between the prior GROWJECT

Identifiants

pubmed: 33446950
doi: 10.1297/cpe.30.35
pii: 2020-0028
pmc: PMC7783130
doi:

Types de publication

Journal Article

Langues

eng

Pagination

35-40

Informations de copyright

2021©The Japanese Society for Pediatric Endocrinology.

Déclaration de conflit d'intérêts

This clinical study was fully sponsored by JCR Pharmaceuticals, Co., Ltd.

Références

Patient Prefer Adherence. 2019 Feb 22;13:351-361
pubmed: 30863023
Rheumatol Ther. 2019 Jun;6(2):245-254
pubmed: 30915626
J Pharm Pharmacol. 1996 Oct;48(10):1012-5
pubmed: 8953501

Auteurs

Yasuko Owada (Y)

Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan.

Yuuka Asano (Y)

Research Division, CMC Development Research, Analytical & Formulation Research Unit, Formulation Development, JCR Pharmaceuticals Co., Ltd., Hyogo, Japan.

Takashi Hanada (T)

Research Division, CMC Development Research, Analytical & Formulation Research Unit, Formulation Development, JCR Pharmaceuticals Co., Ltd., Hyogo, Japan.

Hidehito Yasukawa (H)

Research Division, CMC Development Research, Analytical & Formulation Research Unit, Formulation Development, JCR Pharmaceuticals Co., Ltd., Hyogo, Japan.

Mariko Yamaoka (M)

Development Division, JCR Pharmaceuticals Co., Ltd., Hyogo, Japan.

Yoko Mita (Y)

Development Division, JCR Pharmaceuticals Co., Ltd., Hyogo, Japan.

Noriyuki Namba (N)

Division of Pediatrics and Perinatology, Faculty of Medicine, Tottori University, Tottori, Japan.

Classifications MeSH