Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.

Sponsor
Boehringer Ingelheim
Study ID
NCT01451775
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin — DRUG
    high dose of empagliflozin after overnight fasting for at least 10 h
  • Empagliflozin — DRUG
    low dose empagliflozin after overnight fasting for at least 10 h
  • Empagliflozin — DRUG
    high dose of empagliflozin after a standardised high fat breakfast

Study Details

Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Key Dates

Start date
Oct 31, 2011
Status verified
Jun 2014
Primary completion
Nov 30, 2011

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    high dose of empagliflozin after overnight fasting for at least 10 h
  • Experimental: Treatment B
    high dose of empagliflozin after a standardised high fat breakfast
  • Experimental: Treatment C
    low dose empagliflozin after overnight fasting for at least 10 h

Primary Outcome Measure

Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration ]

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