A RANDOMIZED, TWO-PERIOD, OPEN-LABEL, SINGLE DOSE CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF AQX-1125 IMMEDIATE RELEASE TABLETS AND CAPSULES IN HEALTHY VOLUNTEERS
Completed
- Conditions
- Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)10004994
- Registration Number
- NL-OMON42576
- Lead Sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Gender: Males and/or females
Age: 18 - 55 years, inclusive
BMI: 18.5 * 30.0 kg/m2, inclusive
Status: Healthy subjects
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>Adverse events, clinical laboratory, vital signs, 12-lead electrocardiogram and<br /><br>physical examination<br /><br><br /><br>Pharmacokinetics:<br /><br>Plasma AQX 1125 (and related product) concentrations<br /><br>Plasma PK parameters estimated using noncompartmental analysis, as appropriate:<br /><br>Cmax, tmax, kel, t1/2, AUC0-inf, %AUCextra, AUC0-t, CL/F and Vz/F</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>