A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo

Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in healthy female volunteers.

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (UK)

Belfast, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adult female subjects
18-55 years of age (inclusive)
BMI must be between 18.5 and 27 kg/m2 (inclusive)

Exclusion criteria

Treatment and study plan

RGB-10

Drug

Teriparatide

Drug

Primary outcomes

Area under the plasma concentration versus time curve (AUC)

Time frame: 0-4 hours
Peak Plasma Concentration (Cmax)

Time frame: 0-4 hours

Sponsors and collaborators

Lead sponsor

Gedeon Richter Plc.

Industry

Registry information

Important dates

Primary completion: 2015
First posted: Aug 22, 2014
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed