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

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 - AQX-1125 Bioequivalence Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42576

Enrollment

Registered

2015-09-22

Start date

2015-10-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Interventions

The study will consist of 2 periods. In one period the volunteer will receive a single dose of 200 mg AQX 1125 in the form of an oral capsule (Treatment A), in the other period the volunteer will re

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Safety: Adverse events, clinical laboratory, vital signs, 12-lead electrocardiogram and physical examination Pharmacokinetics: Plasma AQX 1125 (and related product) concentrations Plasma PK parameters estimated using noncompartmental analysis, as appropriate: Cmax, tmax, kel, t1/2, AUC0-inf, %AUCextra, AUC0-t, CL/F and Vz/F	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)