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The purpose of this study is to assess the bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of different formulations of a CGRP receptor antagonist in healthy adult participants.
The study is seeking participants who are:
The study will help the team understand how difference in formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence 1 (Part 1) | Experimental |
| |
| Treatment Sequence 2 (Part 1) | Experimental |
| |
| Treatment Sequence 1 (Part 2) | Experimental |
| |
| Treatment Sequence 2 (Part 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test formulation (Treatment A) | Drug | calcitonin gene-related peptide receptor inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Plasma Concentration-Time profile from time 0 extrapolated to infinite time (AUCinf) of the test and reference formulations | Pre-dose to 72 hours | |
| Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast) of the test and reference formulations | Pre-dose to 72 hours | |
| Maximum Observed Plasma Concentration (Cmax) of test and reference formulations | Predose to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Baseline up to 36 days after the last dose of study intervention |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Reference formulation (Treatment B) | Drug | calcitonin gene-related peptide receptor inhibitor |
|
| Test formulation (Treatment C) | Drug | calcitonin gene-related peptide receptor inhibitor |
|
| Test formulation (Treatment D) | Drug | calcitonin gene-related peptide receptor inhibitor |
|