Bioequivalence Study of Idalopirdine in Healthy Subjects

Bioequivalence Clinical Trial

Official title:

Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 10 mg Commercial Tablet (Test) to the 10 mg Clinical Tablet (Reference)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02894515
• Other study ID #: 16976A
• Secondary ID: 2016-000405-37
• Status: Withdrawn
• Phase: Phase 1
• First received: September 5, 2016
• Last updated: November 10, 2016
• Start date: September 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy men and women with a body mass index (BMI) of >18.5 and <30 kg/m2.

Exclusion Criteria:

• pregnant or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioequivalence

Intervention

Drug:
• Idalopirdine commercial tablet (test)
single dose, 10 mg, oral
• Idalopirdine clinical tablet (reference)
single dose, 10 mg, oral

Locations

Country	Name	City	State
United Kingdom	GB1050	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose		baseline to 72 hours post-dose	No
Primary	Maximum observed concentration of idalopirdine (Cmax)		baseline to 72 hours post-dose	No
Secondary	Time to occurrence of Cmax (tmax)		baseline to 72 hours post-dose	No
Secondary	Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity		baseline to 72 hours post-dose	No
Secondary	Apparent elimination half-life (t1/2)		baseline to 72 hours post-dose	No