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

Information source: Gedeon Richter Plc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: RGB-10 (Drug); Teriparatide (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Gedeon Richter Plc.

Summary

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

Clinical Details

Study design: N/A

Primary outcome:

Area under the plasma concentration versus time curve (AUC)

Peak Plasma Concentration (Cmax)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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:

Locations and Contacts

Celerion (UK), Belfast, United Kingdom
Additional Information


Last updated: March 17, 2015

Page last updated: August 20, 2015

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