Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH

Sponsor
Novo Nordisk A/S
Study ID
NCT01518166
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • liraglutide — DRUG
    Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
  • placebo — DRUG
    Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
  • atorvastatin — DRUG
    One single dose of 40 mg. Tablet
  • lisinopril — DRUG
    One single dose of 20 mg. Tablet
  • griseofulvin — DRUG
    One single dose of 500 mg. Tablet
  • digoxin — DRUG
    One single dose of 1 mg. Tablet

Study Details

The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®), griseofulvin and digoxin (Lanoxin®).

Key Dates

Start date
May 31, 2006
Status verified
Jan 2017
Primary completion
Apr 30, 2007
Completion
Apr 30, 2007

Study Design

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

Arms

  • Experimental: Trial period A
  • Experimental: Trial period B

Primary Outcome Measure

Area under the curve of atorvastatin

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