Evaluating MED2005 & Nitrostat Bioavailability

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 15, 2017

Primary Completion Date

April 16, 2018

Study Completion Date

April 16, 2018

Conditions
Erectile Dysfunction
Interventions
DRUG

MED2005

(Day -1 to Day 1): Subjects will undergo six treatment periods, each separated by at least a two day washout. Each treatment period will be approximately 1 day in duration from the afternoon of Day -1 to the afternoon of Day 1 at 6 hours (h) post-dose. In each of the treatment periods, the subject will receive one of the six administrations over 6 treatment periods (1/period) and will return approximately two days later for the next treatment period.

DRUG

Nitrostat 0.6Mg Sublingual Tablet

Active comparator to be used for Part 1 of the study. Nitrostat will be dosed in two treatment periods and 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose.

DRUG

Nitro Pohl

to be dosed intravenously in Part 2 of the study

Trial Locations (1)

CF48 4DR

Simbec Research Limited, Merthyr Tydfil

All Listed Sponsors
lead

Futura Medical Developments Ltd.

INDUSTRY

NCT04008732 - Evaluating MED2005 & Nitrostat Bioavailability | Biotech Hunter | Biotech Hunter