- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03214159
Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
An Open-label, Randomized Bioequivalence Study (Preliminary Study) of Ritonavir Versus NORVIR in Healthy Chinese Subjects
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- First affiliated Hospital of Zhejiang University
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Hanzhou, Zhejiang, China, 310003
- First affiliated Hospital of Zhejiang University
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Healthy adult volunteers of 18-45 years old.
- Male (weight ≥50kg)
- Body mass index (BMI) between 19~28 kg/m2;
- In good health as determined by a physician/investigator based on medical history, vital signs, electrocardiogram (ECG), laboratory tests and physical examination findings at screening;
- Male participant agrees to use adequate contraception and have no plan to donate sperm from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress;
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
Exclusion Criteria:
- Subject who cannot tolerate venipuncture.
- Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- Abnormal results of physical examination (hematology, urine test,blood biochemistry etc.), vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) or x-ray with clinical significance.
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test;
- Subject who refuse to use adequate contraception from signing of informed consent form throughout the duration of the study and for 6 months after the last dose of study drug;
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as alcohol consumption exceeding 14 units per week) within 6 months preceding this study or is unwilling to agree to abstain from alcohol and drugs throughout the study;
- Heavy smokers (>5 cigarettes per day) within 6 months preceding this study or is unwilling to agree to abstain from smoking throughout the study;
- Positive test results for alcohol or drug at Screening;
- History of hospitalization or surgery within 3 months preceding this study.
- Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
- Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
- Participation in another study with an investigational drug within the last 3 months preceding this study;
- History of gastrointestinal surgery, vagotomy, enterotomy or other surgery that may influence gastrointestinal motility,PH or gastrointestinal absorption.
- Intake of grapefruit or orange (or other food containing grapefruit or orange) 3 days previous to the start of the study. Intake of tea,coffee or other drink containing coffee more than 1L per day.
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive Ritonavir.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: group 1
During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: Ritonavir tablet 100mg cylcle 2 Drug: NORVIR tablet 100mg cylcle 3 Drug: Ritonavir tablet 100mg cylcle 4 Drug: NORVIR tablet 100mg |
Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.
NORVIR Tablet is a generic product manufactured by AbbVie.
NORVIR Tablet 100mg will be used as a comparator drug for the BE study.
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Experimental: group 2
During the study session, healthy subjects will be administered a single dose of Ritonavir or Tablet 100mg or NORVIR tablet 100mg under fasting condition. Intervention: cylcle 1 Drug: NORVIR tablet 100mg cylcle 2 Drug: Ritonavir tablet 100mg cylcle 3 Drug: NORVIR tablet 100mg cylcle 4 Drug: Ritonavir tablet 100mg |
Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.
NORVIR Tablet is a generic product manufactured by AbbVie.
NORVIR Tablet 100mg will be used as a comparator drug for the BE study.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cmax: Maximum Observed Plasma Concentration for ritonavir
Zeitfenster: 36 hours post-dose on Day 1,7,13 and 19
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Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
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36 hours post-dose on Day 1,7,13 and 19
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Tmax
Zeitfenster: 36 hours post-dose on Day 1,7,13 and 19
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Time to Reach the Maximum Plasma Concentration
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36 hours post-dose on Day 1,7,13 and 19
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AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for ritonavir
Zeitfenster: Time Frame: 36 hours post-dose on Day 1,7,13 and 19
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AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity
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Time Frame: 36 hours post-dose on Day 1,7,13 and 19
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AUC(0-36h): Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for ritonavir
Zeitfenster: 36 hours post-dose on Day 1,7,13 and 19
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AUC(0-36h) is measure of area under the plasma concentration and time curve from Time 0 to 36 hours postdose.
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36 hours post-dose on Day 1,7,13 and 19
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Mitarbeiter und Ermittler
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ZYYY-LTNW-BE-2017-05
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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