Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

May 17, 2018

Study Completion Date

May 17, 2018

Conditions
Bioequivalence Study
Interventions
DRUG

Diclofenac Sodium 140mg Medicated Plaster

"Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days.~Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day."

DRUG

Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac

"Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days.~Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day."

Trial Locations (1)

37134

CRC Centro Ricerche Cliniche di Verona s.r.l. c/o Azienda Ospedaliera Universitaria Integrata Verona, Verona

Sponsors
All Listed Sponsors
lead

Fidia Farmaceutici s.p.a.

INDUSTRY