NCT03316820
Completed
Phase 1
A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate Relative Bioavailability of K0706 24 mg Tablet Formulation Relative to 24 mg Capsule Formulation Under Fasted Conditions and to Evaluate the Food Effect for Tablet Formulation in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- K0706
- Conditions
- Healthy
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Observed peak plasma concentration
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements
- •Adult males or females aged between 18 and 55 years
- •Medically healthy on the basis of medical history and physical examination
- •Woman of childbearing potential must practice an acceptable method of birth control
Exclusion Criteria
- •History of any major surgical or medical conditions within 4 weeks prior to dosing
- •History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing
- •Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture
- •Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)
Arms & Interventions
Treatment A
K0706 tablet
Intervention: K0706
Treatment B
K0706 tablet
Intervention: K0706
Treatment C
K0706 tablet
Intervention: K0706
Treatment D
K0706 capsule
Intervention: K0706
Outcomes
Primary Outcomes
Observed peak plasma concentration
Time Frame: 72 hours
Secondary Outcomes
- Adverse event(26 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy VolunteersCancerNCT01827644GlaxoSmithKline36
Terminated
Phase 1
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy ParticipantsHIV InfectionsNCT04128293ViiV Healthcare16
Completed
Phase 1
Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy ParticipantsHealthy VolunteersNCT02981290Hoffmann-La Roche32
Completed
Phase 1
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of PretomanidMulti-drug Resistant TuberculosisNCT04309656Global Alliance for TB Drug Development48
Completed
Phase 1
A Cross-over Study Examining the Bioequivalence of 3 Test Formulations to a Reference Formulation of Alectinib (RO5424802) in Healthy VolunteersHealthy VolunteerNCT02074553Hoffmann-La Roche97