Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
| Group | Value (nanograms times hours/milliliter) | Spread |
|---|---|---|
| Digoxin Only | 16.8 | 25 |
| Digoxin + Dulaglutide | NA | NA |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Study of the Effect of Dulaglutide on How Body Handles Digoxin in Healthy Participants
NCT01436201Sept 2011 to Nov 2011
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body. Information about any side effects that may occur will also be collected. This study is for research purposes only and is not intended to treat any medical condition. This research study requires that a blood sample be obtained and stored for future research involving genetic analysis.
Experimental
Digoxin + Dulaglutide
Digoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
Outcomes the sponsor listed as primary.
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin
Time frame · Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin
Time frame · Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
Time frame · Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (nanograms times hours/milliliter) | Spread |
|---|---|---|
| Digoxin Only | 16.8 | 25 |
| Digoxin + Dulaglutide | NA | NA |
| Group | Value (nanograms per milliliter) | Spread |
|---|---|---|
| Digoxin Only | 1.71 | 27 |
| Digoxin + Dulaglutide | NA | NA |
| Group | Value (hours) |
|---|---|
| Digoxin Only | 1.00 |
| Digoxin + Dulaglutide | NA |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| DigoxinDigoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7. | – | 0 / 24 | 13 / 24 |
| Digoxin + DulaglutideDigoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15. | – | 0 / 21 | 16 / 21 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2017
de la Peña et al. 2017Clinical pharmacokineticscited by 22
PMID 28357715DOI 10.1007/s40262-017-0531-7PUB-28357715
Who could join, as posted.
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