Drug-drug Interaction Study of Aggrenox and Omeprazole in Normal Volunteers

NCT01303445 | Completed Phase 1 Results

• 1 other identifier: 9.197
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the current study is to investigate if a drug-drug interaction occurs with the administration of omeprazole 80 mg q.d. at steady state on the pharmacokinetics of dipyridamole and the pharmacodynamics of ASA-induced platelet aggregation inhibition (components of Aggrenox®) when administered every 12 hours at steady state.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Plasma Dipyridamole Maximum Concentration (Cmax)

  Maximum measured concentration of dipyridamole in plasma

  7 days

• Plasma Dipyridamole Area Under Plasma Concentration-time Curve From Zero to 12 Hours (AUC0-12)

  Area under the concentration time curve of the analyte in plasma from 0 to 12 hours at steady state

  7 days

• Inhibition of Platelet Aggregation at 4 Hours Post Dose (IPA4)

  IPA4 equals the platelet aggregation measured 4 hours post dose divided by the platelet aggregation measured at baseline (multiplied by 100).

  7 days

Secondary Outcomes (3)

• Plasma Dipyridamole Minimum Concentration (Cmin)

  7 days

• Inhibition of Platelet Aggregation at 12 Hours Post Dose (IPA12)

  7 days

• Percentage Peak-to-trough Fluctuation (%PTF)

  7 days

Study Arms (4)

Treatment A

ACTIVE COMPARATOR

Aggrenox alone

Drug: Aggrenox alone

Treatment B

EXPERIMENTAL

Aggrenox and omeprazole

Drug: Aggrenox and omeprazole

Treatment C

ACTIVE COMPARATOR

Omeprazole alone

Drug: Omeprazole alone

Treatment D

EXPERIMENTAL

Aggrenox and omeprazole

Drug: Aggrenox and omeprazole

Interventions

Aggrenox alone DRUG

Aggrenox 1 capsule twice daily for 7 days

Treatment A

Aggrenox and omeprazole DRUG

Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days

Treatment B

Omeprazole alone DRUG

omeprazole 80 once daily for 7 days

Treatment C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure(BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests
• BMI \>18.5 and BMI \<32 kg/m2 (Body Mass Index)

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance in the opinion of the PI
• Any evidence of a clinically relevant concomitant disease
• Clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal, or hematologic (including a history of abnormal bruising) disorders in the opinion of the PI
• Surgery of the gastrointestinal tract that might impair drug absorption
• Clinically significant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to study drugs or its excipients, or reactions to related drugs \[e.g., non-steroidal anti-inflammatory drugs\])
• Intake of drugs with a long half-life (¿24 hours) within one month, or less than 10 half lives of the respective drug, prior to study drug administration or during the trial
• Use of drugs which might reasonably influence the results of the trial (including OTC antacids) based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Tobacco use within the 90 days prior to check-in and throughout the study
• Alcohol abuse within the past 2 years
• Drug abuse within the past 2 years
• Blood donation or other significant blood loss within 56 days (inclusive) prior to screening, or plasma donation within 7 days (inclusive) prior to study drug administration, or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

9.197.001 Boehringer Ingelheim Investigational Site

Tempe, Arizona, United States

Location

MeSH Terms

Interventions

Aspirin, Dipyridamole Drug Combination; Omeprazole

Intervention Hierarchy (Ancestors)

Aspirin; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipyridamole; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2011
• Last Updated: December 24, 2013
• Results First Posted: July 24, 2012

Record last verified: 2012-07

Locations

US (1)