Drug-drug Interaction Study in Healthy Male Volunteers Following the Administration of Pantoprazole and Rosuvastatin

NCT01146483 | Completed Phase 1

• 1 other identifier: CE 09.252
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, 2-period, 2-sequence, cross-over study.

Conditions

Drug Interaction Potentiation

Outcome Measures

Primary Outcomes (1)

• To determine changes induced by pantoprazole administration on the pharmacokinetics of rosuvastatin in healthy volunteers.

  Rosuvastatin will be administered with and without pantoprazole.

  2 weeks

Study Arms (2)

Pantoprazole

ACTIVE COMPARATOR

two-arm study: 2-period, 2-sequence, cross-over study.Volunteers will be administered either sequence 1 or sequence 2 randomly.

Drug: Rosuvastatin, Pantoprazole

Placebo

PLACEBO COMPARATOR

Drug: Rosuvastatin, Pantoprazole

Interventions

Rosuvastatin, Pantoprazole DRUG

Rosuvastatin, 10 mg tablets, single dose on the morning Concomitant drug: Pantoprazole; 40 mg tablets, 2 single doses administered 1 hour before rosuvastatin and 23 hours after rosuvastatin administration. A placebo is given on the other period as a crossover design study.

Also known as: Crestor 10 mg, Pantoloc 40 mg

Pantoprazole; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Vital Signs, EKG and Clinical Laboratory Values within the normal range
• Body mass index (BMI) \[20-29kg/m2\]
• Caucasian male
• Age between \[18-55\]
• Healthy by physical exam
• Non or ex-smoker

You may not qualify if:

• Presence or history of intolerance or hypersensibility to proton pump inhibitors or HMG-CoA reductase inhibitors.
• Significant illness. History of cardiovascular, kidney, liver or gastrointestinal disease. Presence of cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
• consumption of an investigational product or donation of blood in the previous 28 days preceding the study.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2W1T7, Canada

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; Pantoprazole

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pavel Hamet, M.D., Ph.D.

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: June 17, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

CA (1)