A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects

NCT02326233 Phase 1 COMPLETED Results posted

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

Details

Lead sponsor	Samsung Bioepis Co., Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	190
Start date	2015-06
Completion	2015-09

Conditions

• Healthy

Interventions

• Pen of SB5
• PFS of SB5

Primary outcomes

• Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) — 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
• Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) — 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
• Maximum Serum Concentration (Cmax) — 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose

Countries

Belgium, New Zealand