EUCTR2017-001803-57-Outside-EU/EEA
Active, not recruiting
Phase 1
A randomized, study in healthy subjects to determine the bioavailability of 200 mg LCZ696 mini-tablet compared to the 200 mg LCZ696 final market image tablet
ovartis Pharmaceuticals Corp0 sites40 target enrollmentAugust 14, 2017
DrugsEntresto
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Study in healthy subjects
- Sponsor
- ovartis Pharmaceuticals Corp
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female subjects of non\-child bearing potential, age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Other protocol\-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Use of investigational drugs within 30 days or 5 half\-lives of enrollment, whichever is longer. History of symptomatic orthostatic hypotension or syncope or clinically significant ECG abnormalities.
- •Other protocol\-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Not specified
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