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Clinical Trials/NCT02223416
NCT02223416CompletedPhase 1

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

Gedeon Richter Plc.1 site in 1 countryStarted: August 22, 2014Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
1
Primary Endpoint
Peak Plasma Concentration (Cmax)
Study OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

RGB-10

Experimental

Intervention: RGB-10 (Drug)

Forsteo

Active Comparator

Intervention: Teriparatide (Drug)

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Time Frame: 0-4 hours

Area under the plasma concentration versus time curve (AUC)

Time Frame: 0-4 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

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