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This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Individual predicted estimates of Cmax, Tmax, and AUCÏ„ on Day 14 (steady-state) using the final PK model and individual post-hoc estimates of the PK parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anniston | Alabama | 36201 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 34062053 | Derived | Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Anniston |
| Alabama |
| 36207 |
| United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85013 | United States |
| Pfizer Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90211 | United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06511-5473 | United States |
| Pfizer Investigational Site | DeLand | Florida | 32720 | United States |
| Pfizer Investigational Site | Gainesville | Florida | 32607 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Pfizer Investigational Site | Honolulu | Hawaii | 96826 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Bardstown | Kentucky | 40004 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40509 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78209 | United States |
| Pfizer Investigational Site | Slough | Berkshire | SL1 2AD | United Kingdom |
| 19243716 | Derived | Faessel H, Ravva P, Williams K. Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2009 Jan;31(1):177-89. doi: 10.1016/j.clinthera.2009.01.003. |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
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