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

ClinicalTrials.gov · TERMINATED, 2009

24 participants

Abstract

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.

Conditions: Generalized Anxiety Disorder.

Primary outcome: Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf); Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast); Metformin and PD 0332334 half-life (t1/2); Metformin and PD 0332334 maximum plasma concentration.

Enrollment: 24 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 24 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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