Trial reportPharmaceutical research2008
Polyethylene glycol 400 enhances the bioavailability of a BCS class III drug (ranitidine) in male subjects but not females.
Trial report in Pharmaceutical research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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The trial behind it
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Who cites it
19 citing papers in PubMed, 87 citations in OpenAlex.
- Exploring the Impact of Pharmaceutical Excipient PEG400 on the Pharmacokinetics of Mycophenolic Acid Through In Vitro and In Vivo Experiments.International journal of molecular sciences · 2024Article
- Study on the Effect of Pharmaceutical Excipient PEG400 on the Pharmacokinetics of Baicalin in Cells Based on MRP2, MRP3, and BCRP Efflux Transporters.Pharmaceutics · 2024Article
- Sex Differences in Intestinal P-Glycoprotein Expression in Wistar versus Sprague Dawley Rats.Pharmaceutics · 2022Article
- Article
- Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein.The AAPS journal · 2021Article
- Quantification of P-Glycoprotein in the Gastrointestinal Tract of Humans and Rodents: Methodology, Gut Region, Sex, and Species Matter.Molecular pharmaceutics · 2021Observational
- Sex- and Gender-Based Pharmacological Response to Drugs.Pharmacological reviews · 2021Article
- Effect of Food and an Animal's Sex on P-Glycoprotein Expression and Luminal Fluids in the Gastrointestinal Tract of Wistar Rats.Pharmaceutics · 2020Article
- Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies.Cells · 2019Review
- Sex-Dependence in the Effect of Pharmaceutical Excipients: Polyoxyethylated Solubilising Excipients Increase Oral Drug Bioavailability in Male but not Female Rats.Pharmaceutics · 2019Article
- Efficacy and safety of the switch of Triumeq® to generic (abacavir + lamivudine) + Tivicay®: data at 24 weeks.BMC pharmacology & toxicology · 2018Article
- Evaluation of sex-by-formulation interaction in bioequivalence studies of efavirenz tablets.British journal of clinical pharmacology · 2018Article
- The Effects of Pharmaceutical Excipients on Gastrointestinal Tract Metabolic Enzymes and Transporters-an Update.The AAPS journal · 2016Article
- The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers.Pharmaceutical research · 2016Article
- Pharmacogenomics, pharmacokinetics and pharmacodynamics: interaction with biological differences between men and women.British journal of pharmacology · 2014Review
- Impact of osmotically active excipients on bioavailability and bioequivalence of BCS class III drugs.The AAPS journal · 2013Review
- Trends in oral drug bioavailability following bariatric surgery: examining the variable extent of impact on exposure of different drug classes.British journal of clinical pharmacology · 2012Review
- Impact of excipient interactions on drug bioavailability from solid dosage forms.Pharmaceutical research · 2012Review
- Sex differences in drug disposition.Journal of biomedicine & biotechnology · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study was to investigate the effects of different doses of polyethylene glycol 400 (PEG 400) on the bioavailability of ranitidine in male and female subjects.
methodRanitidine (150 mg) was dissolved in 150 ml water with 0 (control), 0.5, 0.75, 1, 1.25 or 1.5 g PEG 400 and administered to 12 healthy human volunteers (six males and six females) in a randomized order. The cumulative amount of ranitidine and its metabolites excreted in urine over 24 h was determined for each treatment using a validated HPLC method.
resultsIn the male volunteers, the mean cumulative amount of ranitidine excreted in the presence of 0, 0.5, 0.75, 1, 1.25 and 1.5 g PEG 400 were 35, 47, 57, 52, 50 and 37 mg respectively. These correspond to increases in bioavailability of 34%, 63%, 49%, 43% and 6% over the control treatment. In the female subjects, the mean cumulative quantity of ranitidine excretion in the absence and presence of increasing amounts of PEG 400 were 38, 29, 35, 33, 33 and 33 mg, corresponding to decreases in bioavailability of 24%, 8%, 13%, 13% and 13% compared to the control. The metabolite excretion profiles followed a similar trend to the parent drug at all concentrations of PEG 400.
conclusionsAll doses of PEG 400 enhanced the bioavailability of ranitidine in male subjects but not females, with the most pronounced effect in males noted with the 0.75 g dose of PEG 400 (63% increase in bioavailability compared to control, p < 0.05). These findings have significant implications for the use of PEG 400 in drug development and also highlight the importance of gender studies in pharmacokinetics.
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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.