Comparative Bioavailability and Local Tolerability of Two Topical Diclofenac Plasters Applied Once and Twice a Day
Condition: Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between
      medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the
      reference medicinal product Flector®, applied once and twice a day.

      Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and
      safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy
      volunteers in comparison to the reference medicinal product Flector®, applied once and twice
      a day.
    

Detailed description: 
      Study Objectives Primary To evaluate the average bioequivalence in healthy volunteers between
      medicinal product of Diclofenac Sodium 140mg Medicated Plaster EQI7 in comparison to the
      reference medicinal product Flector®, both formulated as topical plasters applied once and
      twice a day.

      Secondary To evaluate pharmacokinetic profile on Day 1, adhesivity, local tolerability and
      safety of medicinal product Diclofenac Sodium 140mg Medicated Plaster EQI7 in healthy
      volunteers in comparison to the reference medicinal product Flector®, both formulated as
      topical plasters applied once and twice a day.
    

Intervention name(s): Diclofenac Sodium 140mg Medicated Plaster; Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): EQI7; Flector
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other