Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects.
Administration, Inhalation
Adult
Anti-Asthmatic Agents
/ administration & dosage
Asian People
Cross-Over Studies
Drug Combinations
Female
Glycopyrrolate
/ administration & dosage
Healthy Volunteers
Humans
Indans
/ administration & dosage
Male
Mometasone Furoate
/ administration & dosage
Quinolones
/ administration & dosage
White People
Young Adult
Asthma
Indacaterol/glycopyrronium/mometasone furoate
Japanese–Caucasian
Pharmacokinetics
Journal
BMC pulmonary medicine
ISSN: 1471-2466
Titre abrégé: BMC Pulm Med
Pays: England
ID NLM: 100968563
Informations de publication
Date de publication:
07 Jan 2021
07 Jan 2021
Historique:
received:
19
02
2020
accepted:
16
09
2020
entrez:
8
1
2021
pubmed:
9
1
2021
medline:
7
9
2021
Statut:
epublish
Résumé
A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14. In total, 16 Japanese (median age 31 years [range 20-40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21-43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for C Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups. Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.
Sections du résumé
BACKGROUND
BACKGROUND
A once-daily (o.d.) fixed-dose combination of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF) delivered via the Breezhaler
METHODS
METHODS
This was a single-center, open-label, 2-treatment crossover study with a 21-day washout period. Japanese and Caucasian subjects received IND/GLY/MF 150/50/80 μg (inhaled corticosteroid [ICS] medium-dose) or 150/50/160 μg o.d. (ICS high-dose) for 14 days in each period. Pharmacokinetics were characterized up to 24 h post-dose on Days 1 and 14.
RESULTS
RESULTS
In total, 16 Japanese (median age 31 years [range 20-40 years], mean weight 68.3 kg) and 17 Caucasian subjects (median age 27 years [range 21-43 years], mean weight 75.0 kg) were randomized. Geometric mean ratios (Japanese/Caucasian) [90% confidence interval (CI)] for C
CONCLUSION
CONCLUSIONS
Pharmacokinetics of IND, GLY and MF (high and medium dose) when delivered as a fixed-dose combination were comparable between Japanese and Caucasian subjects. The IND/GLY/MF combination at the administrated doses was safe and well tolerated in both ethnic groups.
TRIAL REGISTRATION
BACKGROUND
Japan Registry of Clinical Trial: jRCT2031200227, retrospectively registered on 04, December, 2020.
Identifiants
pubmed: 33413291
doi: 10.1186/s12890-020-01382-6
pii: 10.1186/s12890-020-01382-6
pmc: PMC7791651
doi:
Substances chimiques
Anti-Asthmatic Agents
0
Drug Combinations
0
Indans
0
Quinolones
0
Mometasone Furoate
04201GDN4R
indacaterol
8OR09251MQ
Glycopyrrolate
V92SO9WP2I
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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