Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Phase 1
Completed
- Conditions
- Chronic Myeloid Leukemia (CML)
- Interventions
- Drug: Imatinib/Acetaminophen
- Registration Number
- NCT00428909
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
A non-randomized, open-label study to investigate the effects of imatinib mesylate on the pharmacokinetics of acetaminophen/paracetamol in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug-Drug interaction Imatinib/Acetaminophen -
- Primary Outcome Measures
Name Time Method To investigate the effects of the co-administration of imatinib on the pharmacokinetics of acetaminophen / paracetamol Day 1, day 2 -7, Day 8 To investigate the pharmacokinetic characteristics of imatinib at steady state in CML-CP patients following 400 mg dosing co-administered with acetaminophen Day 1, Day 2-7, Day 8
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigative Site
🇰🇷Seoul, Korea, Republic of