A Phase 1 interventional study of Ritonavir for cycle1 and NORVIR for cycle 2 and NORVIR for cycle 1 and Ritonavir for cycle 2 in Healthy Volunteer, sponsored by First Affiliated Hospital of Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-21.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting or fed condition.
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 6 days. During each session, the subjects will be administered a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg) under fasting or fed condition.
Exclusion Criteria:
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fasting condition. For group1: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group2: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg
Drug: Ritonavir for cycle1 and NORVIR for cycle 2 · Drug: NORVIR for cycle 1 and Ritonavir for cycle 2
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg or NORVIR tablet 100mg under fed condition. For group3: cycle 1:Ritonavir Tablet 100mg cycle 2:NORVIR tablet 100mg For group4: cycle 1:NORVIR tablet 100mg cycle 2:Ritonavir Tablet 100mg
Drug: Ritonavir for cycle1 and NORVIR for cycle 2 · Drug: NORVIR for cycle 1 and Ritonavir for cycle 2
During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
Cmax
Maximum Observed Plasma Concentration for ritonavir Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: 36 hours post-dose on Day 1,7
Tmax
Time to Reach the Maximum Plasma Concentration
Time frame: 36 hours post-dose on Day 1,7
AUC(0-inf)
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
Time frame: Time Frame: 36 hours post-dose on Day 1,7
AUC(0-36h)
Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
Time frame: 36 hours post-dose on Day 1,7
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital of Zhejiang University