Desmopressin Acetate [amount hidden] Tablets, Fasting

What Was Tested

This registered phase 1 trial tested Desmopressin.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods.

Who Took Part

48 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;. Weighing at least 60 kg for males and 52 kg for females;. Subjects who had a body mass index (BMI) less than 30;. Medically healthy subjects with clinically normal laboratory profiles and ECGs;. Surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof was required for the hysterectomy and oophorectomy;.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: female subjects who were pregnant or lactating; subjects with any medical condition requiring regular treatment with prescription drugs; subjects who did not tolerate venipuncture.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

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

Nothing was hidden in this open-label Desmopressin study: the participants and staff both knew the treatment.

It started in 2003-07 with completion listed for 2003-08.

It ran at 1 site in Canada.

What Was Measured

Primary outcome: Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 12 hour period). AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) (time frame: Blood samples collected over 12 hour period). AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) (time frame: Blood samples collected over 12 hour period).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Desmopressin in 48 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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