DDI (Effect of Metformin and Furosemide on Rosuvastatin PK)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rosuvastatin; Drug: Metformin HCl; Drug: Furosemide

• Registration Number: NCT02574845
• Lead Sponsor: Boehringer Ingelheim

Brief 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)).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-12
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-12
• Study First Posted: 2015-10-14
• Primary Completion: 2015-12-09
• Study Completion: 2015-12-14
• Results First Submitted: 2016-12-08
• Results First Submitted QC: 2016-12-20
• Results First Posted: 2017-02-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T2 (Test 2) Rosuvastatin + Metformin HCl	Metformin HCl	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (50 mg) as single dose, fasted
T1 (Test 1) Rosuvastatin + Metformin HCl	Metformin HCl	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (10 mg) as single dose, fasted
R (Reference) Rosuvastatin	Rosuvastatin	1film-coated tablet as single dose, fasted
T1 (Test 1) Rosuvastatin + Metformin HCl	Rosuvastatin	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (10 mg) as single dose, fasted
T2 (Test 2) Rosuvastatin + Metformin HCl	Rosuvastatin	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (50 mg) as single dose, fasted
T3 (Test 3) Rosuvastatin + Metformin HCl	Metformin HCl	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (500 mg) as single dose, fasted
T3 (Test 3) Rosuvastatin + Metformin HCl	Rosuvastatin	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Metformin HCl (500 mg) as single dose, fasted
T4 (Test 4) Rosuvastatin + Furosemide	Rosuvastatin	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (1 mg) as single dose, fasted
T4 (Test 4) Rosuvastatin + Furosemide	Furosemide	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (1 mg) as single dose, fasted
T5 (Test 5) Rosuvastatin + Furosemide	Rosuvastatin	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (5 mg) as single dose, fasted
T5 (Test 5) Rosuvastatin + Furosemide	Furosemide	Rosuvastatin: 1 film-coated tablet as single dose (10 mg), fasted / Furosemide: (5 mg) as single dose, fasted

Primary Outcome Measures

Name	Time	Method
Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)	Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.	This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Maximum Concentration of Rosuvastatin (Cmax)	Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.	This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)	Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.	This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany