A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

Completed · Phase 1

Conditions studied: Healthy Male Volunteers

In brief

This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.

Key facts

Study ID

NCT03810664

Run by

OPKO Health, Inc.

People needed

49

Starts

2019-01-18

Expected to finish

2019-04-19

Last updated by the study team

2020-04-28

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male volunteers aged 18-55 (inclusive) years
• Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg
• Non-smoking (by declaration) for a period of at least six months prior to screening visit

Where it is running

• QPS Miami Research Associates — Miami, Florida, United States

Full record on ClinicalTrials.gov

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