A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers

Sponsor
Boehringer Ingelheim
Study ID
NCT06360081
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.

Key Dates

First listed
Apr 11, 2024
Start date
Apr 30, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2024
Completion
Jul 15, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Zongertinib (manufacturer 1) Test followed by zongertinb (manufacturer 2) Reference treatment (T-R)
    Participants were administered during Period 1 on Day 1 a single oral dose of 60 milligrams (mg) of zongertinib film-coated tablet produced by Manufacturer 1 (Test treatment, T) with 240 milliliters (ml) of water following an overnight fast of at least 10 hours (hrs). Following a washout period of at least 14 days, participants were administered a single oral dose of 60 mg of zongertinib produced by Manufacturer 2 (Reference treatment, R) with 240 mL of water after an overnight fast of at least 10 hrs.
  • Experimental: Zongertinib (manufacturer 2) Reference followed by zongertinb (manufacturer 1) Test treatment (R-T)
    Participants were administered during Period 1 on Day 1 a single oral dose of 60 mg of zongertinib film-coated tablet produced by Manufacturer 2 (Reference treatment, R) with 240 ml of water following an overnight fast of at least 10 hrs. Following a washout period of at least 14 days, participants were administered a single oral dose of 60 mg of zongertinib produced by Manufacturer 1 (Test treatment, T) with 240 mL of water after an overnight fast of at least 10 hrs.

Primary Outcome Measure

Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to 72h (AUC0-72h) [ Time Frame: Within 3 hours prior to and 0.50, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours after administration of zongertinib Test Treatment and zongertinib Reference Treatment. ]

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