Trial reportClinical drug investigation2018
Non-Compartmental Pharmacokinetics and Safety of Single-Dose Eldecalcitol (ED-71) in Healthy Chinese Adult Males.
Trial report in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects.Clinical pharmacology in drug development · 2022Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
BACKGROUND AND
objectivesEldecalcitol (ED-71) is a novel active vitamin D
methodsThis was an open, single-center, randomized, two-dose level, two-period crossover phase I study in 24 healthy Chinese adult males. Eligible subjects received a single oral dose of eldecalcitol capsule 0.5 or 0.75 μg at period 1 or period 2, monitored over a 144-h observation period for pharmacokinetics and a 14-day observation period for safety. The wash-out time was 14 days. The data observed in this study were compared with historical data in Japanese subjects to evaluate the inter-ethnic differences in pharmacokinetics.
resultsAfter single doses of 0.5 and 0.75 μg eldecalcitol, the maximum serum concentration (C
conclusionPharmacokinetic exposure (C CLINICAL
trial registrationThis study was registered at the China Food and Drug Administration (Registration number: 2014L02212 and 2014L02213), and also registered at http://www.chinadrugtrials.org.cn (No. CTR20160430).
Indexed as
Identifiers
30117129What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.