Evidence map›Paper›PMID 35018094›Full record

Trial reportDrug design, development and therapy2022

Open-Label, Phase I, Pharmacokinetic Studies in Healthy Chinese Subjects to Evaluate the Bioequivalence and Food Effect of a Novel Formulation of Abiraterone Acetate Tablets.

Zeying Feng, Yaxin Liu, Yun Kuang, Shuang Yang, Jinlei Li, Ling Ye, Jie Huang, Qi Pei, Yuanyuan Huang, Guoping Yang

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug design, development and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 7 citations in OpenAlex.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Zeying Feng *XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Yaxin Liu *XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Yun KuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Shuang YangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Jinlei LiCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Ling YeCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Jie HuangCenter of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Qi PeiDepartment of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, 410013, People's Republic of China.ORCID 0000-0002-6711-4251
Yuanyuan HuangXiangYa School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, 410013, People's Republic of China.
Guoping YangXiangYa School of Pharmaceutical Sciences, Central South University, Changsha, Hunan, 410013, People's Republic of China.ORCID 0000-0001-5930-586X
Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAbiraterone acetate tablets (I)(N-AbA) is a novel tablet co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). This study aimed to compare the pharmacokinetics, bioequivalence, safety, and food effects of N-AbA with the reference ZYTIGA PATIENTS AND

methodsThis study was conducted in three parts. Part I was an open, dose-escalation trial conducted in 16 Chinese healthy males; Part II was a randomized, open-label, 2 × 4 crossover, single-dose bioequivalence trial conducted in 36 subjects; Part III was a randomized, 3 × 3 crossover trial conducted on 24 volunteers to investigate the effect of food on the pharmacokinetics of N-AbA.

resultsThe exposure (AUC

conclusionThese three Phase I trials showed that N-AbA and excipient SNAC had excellent linear pharmacokinetic characteristics. A single dose of N-AbA 300 mg was bioequivalent to R-AbA 1000 mg in healthy subjects under fasting conditions. Meanwhile, SNAC had no effect on the pharmacokinetics of prednisone and prednisolone. The effect of food on N-AbA was significantly lower than that on R-AbA.

Indexed as

Abiraterone AcetateAdministration, OralBiological AvailabilityCaprylatesChinaCross-Over StudiesDiet, High-FatDrug CompoundingFastingHumansMaleTabletsTherapeutic EquivalencyAbiraterone AcetateCaprylatesN-(8-(2-hydroxybenzoyl)amino)caprylateTabletsabiraterone acetatebioequivalencefood effectpharmacokinetics

Identifiers

PMID35018094
PMCPMC8740623
OpenAlexW4206439467

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.