A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users
Phase: PHASE1
Conditions: Respiratory Depression
Sponsor: BioDelivery Sciences International

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PRAHEALTHSCIENCES 
CLINICAL STUDY PROTOCOL 
BUP-401 /BDL673SL-186739 
VERSION 2.0- 6-Aug-2019 
AUTHORIZATION OF CLINICAL STUDY PROTOCOL BY CONTRACT 
RESEARCH ORGANIZATION 
The Sponsor and the Contract Research Organization agree to conduct the study as outlined in this 
CSP. Any modification of the CSP must be agreed upon by the Sponsor and the Contract Research 
Organization and must be documented in writing. 
Name/Position: 
Contract Research Organization: PRA Health Sciences - EDS 
 
 
Signature: 
Strictly Confidential. © 2018, PRA Health Sciences. All rights reserved. 
Page 3 of 57 

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