DDI (Effect of Metformin and Furosemide on Rosuvastatin PK)

Phase 1 Completed 18 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this trial is to investigate the relative bioavailability of rosuvastatin when given alone (Reference treatment, R) compared to when given together with one of the three different doses of metformin (10 mg, Test treatment 1 (T1); 50 mg (T2); 500 mg (T3)) or one of the two doses of furosemide (1 mg (T4); 5 mg (T5)).

Timeline

Start: 2015-10-12
Primary completion: 2015-12-09
Completion: 2015-12-14

Publications

Stopfer P, Giessmann T, Hohl K, Sharma A, Ishiguro N, Taub ME, Jungnik A, Gansser D, Ebner T, Muller F. Effects of Metformin and Furosemide on Rosuvastatin Pharmacokinetics in Healthy Volunteers: Implications for Their Use as Probe Drugs in a Transporter Cocktail. Eur J Drug Metab Pharmacokinet. 2018 Feb;43(1):69-80. doi: 10.1007/s13318-017-0427-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Furosemide	Other / unclassified	1 mg	—
Subject	Furosemide	Other / unclassified	5 mg	—
Subject	Metformin	Small molecule	10 mg	—
Subject	Metformin	Small molecule	50 mg	—
Subject	Metformin	Small molecule	500 mg	—
Subject	Rosuvastatin	Small molecule	10 mg	Oral

Indications

No indication recorded.