SMP-028/midazolam drug: drug interaction study

Not Applicable

Completed

• Conditions: Asthma; Respiratory

• Registration Number: ISRCTN47498012
• Lead Sponsor: Dainippon Sumitomo Pharma Europe Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-15
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Healthy subjects aged 18 to 55 years who are in good health as determined by past medical history, physical examination, electrocardiogram, clinical safety laboratory tests and urinalysis

Exclusion Criteria

Standard exclusion criteria for a healthy volunteer study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics:<br>1. Primary endpoints: <br>Comparative midazolam exposure between treatment periods (AUC[0-8] and C[max]) over 24 hours <br>2. Secondary endpoints: <br>Comparative midazolam exposure between treatment periods (other pharmacokinetic parameters), and exposure levels of the active metabolite a-hydroxymidazolam over 24 hours.

Secondary Outcome Measures

Name	Time	Method
2. Safety: <br>2.1. The proportion of subjects with adverse events (AEs)<br>2.2. Changes in standard laboratory safety tests: <br>2.2.1. Haematology<br>2.2.2. Clinical chemistry<br>2.2.3. Urinalysis<br>2.3. Concomitant medication review<br>2.4. Vital signs<br>2.5. Complete physical examinations <br>2.6. 12-lead ECG