NCT00809536

Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body 2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body 3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Detailed description

Detailed Description: Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration. On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Metformin	225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
DRUG	Metformin	Single, oral, 500 mg of metformin immediate release
DRUG	PD 0332334	500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
DRUG	PD 0332334	Single, oral, 300 mg dose of PD 0332334 immediate release formulation

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-12-17
• Last updated: 2010-02-17

Locations

1 site across 1 country: Singapore