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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01518166 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1608Other id2006-000175-15

Overview

Status
Completed
Phase
Phase 1
Enrollment
70 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Sweden

Start
May 2006
Primary completion
Apr 2007
Completion
Apr 2007
First posted
25 Jan 2012 (estimated)
Last update posted
25 Jan 2017 (estimated)
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 1

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

    NCT01518166

    May 2006 to Apr 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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®).

Interventions

  • liraglutideDrug
  • placeboDrug
  • atorvastatinDrug
  • lisinoprilDrug
  • griseofulvinDrug
  • digoxinDrug

Arms2

  • Experimental

    Trial period A

  • Experimental

    Trial period B

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Area under the curve of atorvastatin

  2. Area under the curve of lisinopril

  3. Area under the curve of griseofulvin

  4. Area under the curve of digoxin

Secondary outcomes(6)
  1. Area under the curve of liraglutide

  2. Cmax, maximum concentration

  3. tmax, time to reach Cmax

  4. Terminal elimination rate constant

  5. Intragastric pH

  6. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

9 results

Effect on the Gastrointestinal Absorption of Drugs from Different Classes in the Biopharmaceutics Classification System, When Treating with Liraglutide.

Malm-Erjefält et al. 2015Molecular pharmaceuticscited by 25

PMID 26426736DOI 10.1021/acs.molpharmaceut.5b00278PUB-26426736

Full text at the publisher9 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Female subjects if using adequate anti-contraception or is sterile * Body Mass Index (BMI) of 18-30 kg/m\^2 (both inclusive) * Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments * Willing and capable to self-administer a subcutaneous injection Exclusion Criteria: * History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator * Impaired renal function * Blood pressure and heart rate in supine position outside the ranges 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min * Any clinically significant abnormal ECG * Active hepatitis B and/or active hepatitis C * Positive HIV (human immunodeficiency virus) antibodies * Known or suspected allergy to trial product(s) or related products * Use of any prescription or non-prescription medication except for paracetamol, nasal spray or drops for nasal congestion, and vitamins within 2 weeks prior to first dosing and during the entire trial period * History of alcoholism or drug abuse during the last 12 months * Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator

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