Evidence map›Paper›PMID 39006193›Full record

Trial reportDrug design, development and therapy2024

Pharmacokinetics and Safety of Estradiol Valerate Tablet and Its Generic: A Phase 1 Bioequivalence Study in Healthy Chinese Postmenopausal Female Subjects.

Li Zhang, Mupeng Li, Lianlian Fan, Fangfang Liu, Peiwen Zhang, Qian Huang, Gang Mai, Jianzhong Shentu

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Estradiol Valerate Tablets Caused Rare Severe Drug Eruption: The First Reported Case.Clinical, cosmetic and investigational dermatology · 2024
    Article
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

8 authors.

Li Zhang *Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Mupeng Li *Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Lianlian FanPhase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Fangfang LiuPhase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Peiwen ZhangPhase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Qian HuangPhase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Gang MaiPhase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.
Jianzhong ShentuPhase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Estradiol valerate (Progynova Methods: A randomized, open-label, single-dose, 2-period crossover study was conducted on healthy postmenopausal Chinese female volunteers under fasting and fed conditions. For each period, the subjects received either a 1 mg tablet of estradiol valerate or its generic. Blood samples were collected before dosing and up to 72 hours after administration. Plasma levels of total estrone, estradiol, and unconjugated estrone were quantified using a validated liquid chromatography-tandem mass spectrometry method. Results: A total of 54 volunteers were enrolled in this study. The primary pharmacokinetic parameters, including C Conclusion: Estradiol valerate and its generic form were bioequivalent and well tolerated under both fasting and fed conditions.

Indexed as

Drugs, GenericEstradiolPostmenopauseAdministration, OralChinaCross-Over StudiesEast Asian PeopleFemaleHealthy VolunteersHumansMiddle AgedTabletsTherapeutic EquivalencyDrugs, GenericEstradiolTabletsbioequivalenceestradiol valeratepharmacokineticspostmenopausalsafety

Identifiers

PMID39006193
PMCPMC11246651

What OpenQuestion 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 OpenQuestion graph.