A replicate study design for testing bioequivalence: a case study on two desmopressin nasal spray preparations

What Was Tested

Researchers studied Vasopressin and Desmopressin in this randomized controlled trial publication.

The present study was carried out to test bioequivalence between two different desmopressin nasal spray preparations.

Who Took Part

The age groups tagged for this paper are adults, men only.

Thirty-two healthy male volunteers were enrolled in the study and were randomly assigned to receive the test- and reference drug on two occasions in a 4-period 2-sequence crossover study design.

Statistical analysis was initially performed using a complicated mixed-analysis model testing for individual bioequivalence according to recommendations by the Food and Drug Administration.

How the Study Was Run

The design is described as randomized and crossover.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

Each person switched between Vasopressin and the comparison at some point, usually with a gap in between.

Desmopressin blood concentrations were measured serially over a 14-h period using a validated radioimmunoassay method.

This approach, however, failed to converge with all defined main PK parameters and, thus, a traditional mixed analysis of variance analysis based on population averages was definitely used for testing bioequivalence between study drugs.

The procedure of selecting an appropriate statistical analysis for a replicate study design was predefined in the study protocol.

What Was Measured

The subject headings attached to it are Area Under Curve, Data Interpretation, Statistical, Deamino Arginine Vasopressin, Half-Life, Renal Agents, Reproducibility of Results and Therapeutic Equivalency.

What This Means in Plain Language

The paper is a randomized and crossover study of Vasopressin and Desmopressin.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2003 (European journal of clinical pharmacology), a journal based in Germany.

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