Evidence map›Paper›PMID 15230337›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics

Bioequivalence evaluation of two rabeprazole enteric coated formulations in healthy Chinese volunteers.

Jun Chen, Wen Ming Jiang, Xiao Ling Gao, Xinguo Jiang, Qi Zhi Zhang, Zhao Hua Zheng

Abstract readClinical TrialComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. 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

6 authors.

Jun ChenDepartment of Pharmaceutics, School of Pharmacy, Fudan University, Shanghai, PR China.
Wen Ming Jiang
Xiao Ling Gao
Xinguo Jiang
Qi Zhi Zhang
Zhao Hua Zheng

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A bioequivalence study of two rabeprazole enteric-coated formulations was carried out in 20 healthy Chinese volunteers according to a single dose, two-sequence, crossover randomized design. The two formulations were administered in two treatment days, separated by a washout period of 7 days. Blood samples were collected at specified time intervals over 10 hours post-dosing. Plasma samples were separated and assayed for rabeprazole using a selective and sensitive HPLC method with UV detection. The pharmacokinetic parameters AUC(0-T), AUCmax, Cmax, tmax, t(1/2) and MRT were determined from plasma concentration-time profile of both formulations. ANOVA and two one-sided t test procedures showed no significant difference in log-transformed Cmax, AUC(0-T) AUC(0-infinity) while the 90% confidence interval (CI) of the ratio of the geometric means of their values were also used to assess bioequivalence between the two formulations. The results of this study indicated that the two rabeprazole formulations can be considered to be bioequivalent.

Indexed as

2-PyridinylmethylsulfinylbenzimidazolesAdultBenzimidazolesBiological AvailabilityCapsulesChemistry, PharmaceuticalChromatography, High Pressure LiquidCross-Over StudiesDouble-Blind MethodEnzyme InhibitorsHumansMaleOmeprazoleRabeprazoleSpectrophotometry, UltravioletTablets, Enteric-Coated2-PyridinylmethylsulfinylbenzimidazolesBenzimidazolesCapsulesEnzyme InhibitorsOmeprazoleRabeprazoleTablets, Enteric-Coated

Identifiers

PMID15230337

What OpenQuestion holds

Textmetadata
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.