Bioequivalence Study of Empagliflozin & Metformin HCL From Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)

Sponsor
Genuine Research Center, Egypt
Study ID
NCT05132023
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin & Metformin (Test) — DRUG
    one tablet administrated according to a randomization scheme with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing.
  • Empagliflozin & Metformin (Reference) — DRUG
    one tablet administrated according to a randomization scheme with 240 mL of a 20% glucose solution in water, followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing.

Study Details

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Empagliflozin \& Metformin HCL from Empagliform 12.5/1000 mg F.C.T (Hikma Pharma, Egypt) and Synjardy 12.5/1000 mg F.C.T (Boehringer Ingelheim International GmbH, Germany)

Key Dates

Start date
Mar 26, 2019
Status verified
Nov 2021
Primary completion
Apr 2, 2019
Completion
May 15, 2019

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Empagliform
    Test drug
  • Active Comparator: Synjardy
    Reference drug

Primary Outcome Measure

Cmax [ Time Frame: Up to 72 hours post dose in each treatment period ]

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