Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 23, 2018

Primary Completion Date

August 5, 2018

Study Completion Date

August 5, 2018

Conditions
Healthy
Interventions
DRUG

Ketoprofen Lysine

A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

DRUG

Ketoprofen Oral Product

A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

Trial Locations (1)

CH-6864

CROSS Research S.A., Phase I Unit,, Arzo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cross Research S.A.

INDUSTRY

lead

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY