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Effect of grapefruit juice on the pharmacokinetics of tolvaptan, a non-peptide arginine vasopressin antagonist, in healthy subjects.

Plain-language guide to PMID 21853290 (2012): crossover randomized controlled trial of Tesofensine (non-peptide) and Nootropic adjuncts (non-peptide) in 20 subjects.

Key Facts

PMID
21853290
Journal
European journal of clinical pharmacology
Year
2012
Study type
Randomized Controlled Trial
Authors
Shoaf SE et al. (3 authors)
DOI
10.1007/s00228-011-1106-4

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Tesofensine (non-peptide) and Nootropic adjuncts (non-peptide), published as a randomized controlled trial.

In vitro studies indicated that tolvaptan was a CYP3A4 substrate.

Who Took Part

According to the abstract, 20 subjects were involved.

By PubMed's age tags, the people studied were teenagers, young adults, adults and middle-aged adults, both men and women.

How the Study Was Run

In design terms this was a randomized and crossover study.

The subjects were allocated by chance, so the Tesofensine (non-peptide) group and the comparison group should start out alike.

In the crossover set-up each of the subjects took both Tesofensine (non-peptide) and the comparison in turn, acting as their own control.

Blood samples for tolvaptan plasma concentrations were obtained for 48 h postdose.

What Was Measured

PubMed files the paper under topics including Antidiuretic Hormone Receptor Antagonists, Benzazepines, Beverages, Biological Availability, Citrus paradisi, Diuretics and Food-Drug Interactions.

What This Means in Plain Language

The paper is a randomized and crossover study of Tesofensine (non-peptide) and Nootropic adjuncts (non-peptide) in 20 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2012 (European journal of clinical pharmacology), a journal based in Germany.

More context: the Tesofensine (non-peptide) compound page and the Nootropic adjuncts (non-peptide) compound page, all human trials.

Our Notes on the Compounds

Tesofensine (non-peptide): An oral triple reuptake inhibitor (serotonin, norepinephrine, dopamine).

Nootropic adjuncts (non-peptide): Phenylpiracetam hydrazide: Needs alpha-GPC about 30 minutes before it, or tolerance develops in 2–3 days.

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.