Bioequivalence Study of Idalopirdine Tablets 60 mg

Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 60 mg Commercial Tablet (Test) to the 60 mg Clinical Tablet (Reference)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02371707

Enrollment

Registered

2015-02-26

Start date

2015-03-31

Completion date

2015-04-30

Last updated

2015-05-07

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

Conditions

Healthy

Brief summary

This study aims to establish bioequivalence between two tablet formulations of idalopirdine

Interventions

DRUGIdalopirdine 60 mg formulation A (test)

Tablet for oral use, single dose

DRUGIdalopirdine 60 mg formulation B (reference)

Tablet for oral use, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men and women -≥18 and ≤55 years of age * body mass index (BMI) of \>18.5 and \<30 kg/m2

Exclusion criteria

* Pregnant and lactating women Other protocol defined inclusion and

Design outcomes

Primary

Measure	Time frame
Area under the idalopirdine plasma concentration-time curve	0 to 72 hours post-dose
maximum observed concentration (Cmax) of idalopirdine	0 to 72 hours post-dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026