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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: RGB-10; Drug: Teriparatide

• Registration Number: NCT02223416
• Lead Sponsor: Gedeon Richter Plc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-08
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Primary Completion: 2015-01
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RGB-10	RGB-10	-
Forsteo	Teriparatide	-

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	0-4 hours
Area under the plasma concentration versus time curve (AUC)	0-4 hours

Trial Locations

Locations (1)

Celerion (UK); 🇬🇧 Belfast, United Kingdom