Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe.

The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).

It had two arms (groups): Formulation 4 (experimental) and Final formulation 4 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 22 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments. BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: impaired renal function; active hepatitis b and/or active hepatitis c; positive human immunodeficiency virus (hiv) antibodies.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2007-01 with completion listed for 2007-04.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the curve (0-t). Cmax, maximum concentration.

It also tracked 6 secondary outcomes, for example Area under the curve (0-infinity), Relative bioavailability, Time to reach maximum (tmax), Terminal elimination half life (t½), Terminal elimination rate constant and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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