NCT02223416 is a Phase 1 clinical trial of RGB-10 in Healthy, sponsored by Gedeon Richter Plc..

Who is sponsoring NCT02223416?

NCT02223416 is sponsored by Gedeon Richter Plc..

What drugs are being tested in NCT02223416?

Interventions in NCT02223416: RGB-10, Teriparatide.

Is NCT02223416 still recruiting?

NCT02223416 is currently completed. Last updated 17 March 2015.

Last reviewed 2015-03-17 · How we verify

NCT02223416

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 17 March 2015

What this trial tests

Phase 1 trial testing RGB-10 in Healthy. Completed.

Quick facts

Lead sponsor	Gedeon Richter Plc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary completion	1 January 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

RGB-10 — full drug profile →
Teriparatide — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Gedeon Richter Plc. — full company profile →

Who can join

Adults 18 to 55, female only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The first biosimilar approved for the treatment of osteoporosis: results of a comparative pharmacokinetic/pharmacodynamic study.
Takács I, Jókai E, Kováts DE, Aradi I. · · 2019 · cited 14× · PMID 30357438 · DOI 10.1007/s00198-018-4741-0
A multicenter, randomized, rater-blinded, parallel-group, phase 3 study to compare the efficacy, safety, and immunogenicity of biosimilar RGB-10 and reference once-daily teriparatide in patients with osteoporosis.
Hagino H, Narita R, Yokoyama Y, Watanabe M, et al · · 2019 · cited 9× · PMID 31243480 · DOI 10.1007/s00198-019-05038-y

Verify or expand the search:

Other recruiting trials for Healthy

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Other Gedeon Richter Plc. trials

Trials by the same sponsor.

NCT06990204 — Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC · Phase 1 · not yet recruiting
NCT06823856 — Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets ( · Phase 1 · completed
NCT06792968 — Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Ged · Phase 1 · completed
NCT06766500 — Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gede · Phase 1 · completed
NCT05322096 — Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02223416 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gedeon Richter Plc.
Last refreshed: 17 March 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02223416.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing