NCT00681395CompletedPhase 1
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Adverse event and safety laboratory assessments
Study Overview
Brief Summary
To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •General good health
- •BMI 19 to 29
Exclusion Criteria
- •Currently enrolled in another study
- •Females who are pregnant or breastfeeding
Arms & Interventions
1
Experimental
ABT-143 capsules 20/135 mg
Intervention: ABT-143 (Drug)
2
Active Comparator
ABT-335 135mg and rosuvastatin 20mg
Intervention: ABT-335 (Drug)
2
Active Comparator
ABT-335 135mg and rosuvastatin 20mg
Intervention: Rosuvastatin (Drug)
3
Experimental
ABT-143 capsules 5/45mg
Intervention: ABT-143 (Drug)
4
Active Comparator
ABT-335 45mg and rosuvastatin 5mg
Intervention: ABT-335 (Drug)
4
Active Comparator
ABT-335 45mg and rosuvastatin 5mg
Intervention: Rosuvastatin (Drug)
Outcomes
Primary Outcomes
Adverse event and safety laboratory assessments
Time Frame: 7 days
Pharmacokinetic parameters
Time Frame: 7 days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form.Adverse EventsPharmacokinetic VariablesNCT00728780AstraZeneca32
Completed
Phase 1
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected SubjectsHCV InfectionNCT00696904AbbVie133
Completed
Phase 1
Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With CancerSolid TumorNCT00888108Abbott41
Completed
Phase 1
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic FunctionHepatic ImpairmentNCT02296905AbbVie24
Completed
Phase 3
30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney DiseaseDyslipidemiaKidney DiseaseNCT00680017AstraZeneca280