Claiming desmopressin therapeutic equivalence in children requires pediatric data: a population PKPD analysis

What Was Tested

The paper reports a study of Vasopressin and Desmopressin, published as a controlled clinical trial.

The main objective was the comparison of the therapeutic equivalence of two desmopressin formulations: tablet and lyophilisate.

Who Took Part

The study group was 18 children.

By PubMed's age tags, the people studied were children and teenagers, both men and women.

How the Study Was Run

The design is described as crossover and pilot.

In the crossover set-up each of the children took both Vasopressin and the comparison in turn, acting as their own control.

It is described as a pilot, a small early test of whether a larger Vasopressin study would be practical.

What Was Measured

PubMed files the paper under topics including Administration, Sublingual, Age Factors, Antidiuretic Agents, Deamino Arginine Vasopressin, Drug Compounding, Freeze Drying and Kidney Concentrating Ability.

Author keywords: 1-Deamino-8-D-arginine vasopressin (dDAVP), Bioequivalence, Children, Lyophilisate, PKPD modeling and Tablet.

What This Means in Plain Language

The paper is a crossover and pilot study of Vasopressin and Desmopressin in 18 children.

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 2018 (European journal of clinical pharmacology), a journal based in Germany.

More context: the Vasopressin compound page and the Desmopressin compound page, all human trials.