The primary purpose of this study is to determine the Pharmacokinetics (PK) data of perfluorobutane (PFB) in blood and exhaled air following intravenous (I.V.) bolus injection of Sonazoid™ in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu
Chaoyang, Beijing Municipality, China
Area Under the Concentration Versus Time Curve from Time Zero to the Last Time- Point (AUC 0-last), AUC from Time Zero to Infinity (AUC0-infinity∞) After Single Dose in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Area Under the Concentration Versus Time Curve from Time Zero to the Last Time- Point (AUC 0-last), AUC from Time Zero to Infinity (AUC0-Infinity∞) After Single Dose in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Rate Constant (kel) in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Elimination Rate Constant (kel) in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Half-life (t½) in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Elimination Half-life (t½) in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Clearance (Cl) in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clearance (Cl) in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Maximum Observed Concentration (Cmax) in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Maximum Observed Concentration (Cmax) in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Time at which Cmax is reached (tmax) in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Time at which Cmax is reached (tmax) in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Volume of Distribution (Vd) in Blood
Time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Volume of Distribution (Vd) in Exhaled Air
Time frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Percentage of Participants With Treatment-Related Adverse Events (AEs)
Time frame: Up to 72 hours after first administration of investigational medicinal product (IMP)
Percentage of Participants With Abnormal Laboratory Values
Time frame: Up to 4 hours post dose
Percentage of Participants With Abnormal Vital Signs
Time frame: Up to 4 hours post dose
Percentage of Participants With Injection Site Reactions
Time frame: Up to 4 hours post dose
Percentage of Participants With Abnormal Physical Examinations
Time frame: Up to 4 hours post dose