Trial reportBritish journal of clinical pharmacology2013
Simultaneous oral therapeutic and intravenous ¹⁴C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin.
Trial report in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.
What it found
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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
35 citing papers in PubMed.
- Absolute oral bioavailability of milvexian spray-dried dispersion formulation under fasted and fed conditions in healthy adult participants: An intravenous microtracer approach.Clinical and translational science · 2024Trial
- Model-Informed Pediatric Dose Selection for Dapagliflozin by Incorporating Developmental Changes.CPT: pharmacometrics & systems pharmacology · 2021Trial
- Physiologically-Based Pharmacokinetic Modeling of the Drug-Drug Interaction of the UGT Substrate Ertugliflozin Following Co-Administration with the UGT Inhibitor Mefenamic Acid.CPT: pharmacometrics & systems pharmacology · 2021Trial
- Determination of the absolute oral bioavailability of niraparib by simultaneous administration of aCancer chemotherapy and pharmacology · 2018Trial
- Absolute bioavailability of evacetrapib in healthy subjects determined by simultaneous administration of oral evacetrapib and intravenous [(13) C8 ]-evacetrapib as a tracer.Journal of labelled compounds & radiopharmaceuticals · 2016Trial
- Stable isotope-labelled intravenous microdose for absolute bioavailability and effect of grapefruit juice on ibrutinib in healthy adults.British journal of clinical pharmacology · 2016Trial
- A Phase 1 Oral Mass Balance and Combined Intravenous [Journal of clinical pharmacology · 2026Article
- Multicomponent Salts of the Antidiabetic Agent Saxagliptin: Hydration-Assisted Assembly and Lipophilic Aggregation with Carboxylic Acids.ACS omega · 2026Article
- A Physiologically Based Pharmacokinetic and Pharmacodynamic (PBPK/PD) Model of Dapagliflozin in Type 2 Diabetes Mellitus: The Effect of Dosing, Hepatorenal Impairment, and Food.Pharmaceutics · 2026Article
- Exploring the Role of SGLT2 Inhibitors in Cancer: Mechanisms of Action and Therapeutic Opportunities.Cancers · 2025Review
- The application of Phase 0 and microtracer approaches in early clinical development: past, present, and future.Frontiers in pharmacology · 2024Review
- Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Impact of Chronic Kidney Disease on CYP3A4-Mediated Metabolism of Saxagliptin.Journal of clinical pharmacology · 2022Article
- A Phase 1 Study to Assess Mass Balance and Absolute Bioavailability of Zimlovisertib in Healthy Male Participants Using aClinical pharmacology in drug development · 2022Article
- Exenatide and Dapagliflozin Combination Enhances Sertoli Cell Secretion of Key Metabolites for Spermatogenesis.Biomedicines · 2022Article
- Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination.Clinical pharmacology in drug development · 2021Article
- PBPK Modeling as a Tool for Predicting and Understanding Intestinal Metabolism of Uridine 5'-Diphospho-glucuronosyltransferase Substrates.Pharmaceutics · 2021Review
- Review
- Application of Physiologically-Based Pharmacokinetic Modeling to Predict Gastric pH-Dependent Drug-Drug Interactions for Weak Base Drugs.CPT: pharmacometrics & systems pharmacology · 2020Article
- A Phase 1, Open-Label Study in Healthy Subjects to Evaluate the Absolute Bioavailability of AG-221 by a Microtracer Approach.Oncology and therapy · 2020Article
- Possibility of pharmacokinetic drug interaction between a DPP-4 inhibitor and a SGLT2 inhibitor.Translational and clinical pharmacology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo determine the absolute oral bioavailability (F(p.o.) ) of saxagliptin and dapagliflozin using simultaneous intravenous ¹⁴C-microdose/therapeutic oral dosing (i.v.micro + oraltherap).
methodsThe F(p.o.) values of saxagliptin and dapagliflozin were determined in healthy subjects (n = 7 and 8, respectively) following the concomitant administration of single i.v. micro doses with unlabelled oraltherap doses. Accelerator mass spectrometry and liquid chromatography-tandem mass spectrometry were used to quantify the labelled and unlabelled drug, respectively.
resultsThe geometric mean point estimates (90% confidence interval) F(p.o) . values for saxagliptin and dapagliflozin were 50% (48, 53%) and 78% (73, 83%), respectively. The i.v.micro had similar pharmacokinetics to oraltherap.
conclusionsSimultaneous i.v.micro + oraltherap dosing is a valuable tool to assess human absolute bioavailability.
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Registered trials
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