QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorQilu Pharmaceutical (Hainan) Co., Ltd.

About this trial

This is a single-center, single-dose, randomized, open-label, crossover study. Forty-two healthy male and female participants will be enrolled. The study will consist of 3 periods in which participants will receive either the test product QLM2010 (18 mL: aprepitant 130 mg and palonosetron hydrochloride 0.25 mg, manufactured by Qilu Pharmaceutical \[Hainan\] Co., Ltd.) or the Reference Product 1 (aprepitant injection CINVANTI®, 18 mL: 130 mg, manufactured by Alcami Carolinas Corp.) or the Reference Product 2 (palonosetron hydrochloride injection, 5 mL: 0.25 mg, manufactured by Dr Reddys Laboratories Ltd.) by intravenous injection under fasting conditions in each period. The washout period between 2 consecutive doses will be at least 14 days. Plasma concentrations of aprepitant and palonosetron at different sampling times will be determined by HPLC-MS/MS. Pharmacokinetic parameters will be calculated using noncompartmental analysis (NCA) and subjected to statistical analysis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

To voluntarily sign the informed consent form before the study, and fully understand the content, process and possible adverse reactions of the study;

Ability to complete the study in accordance with the protocol requirements;

Participants (including male participants) must use effective contraceptive methods for 14 days prior to the first dose and voluntarily agree to maintain effective contraception from signing the informed consent until 3 months after the last dose, with no plans for pregnancy, sperm donation, or oocyte donation during this period. Specific contraceptive requirements are detailed in Appendix 1.

Male and female participants aged 18 to 55 years, inclusive;

Disqualifiers

History or presence of any clinically significant disorder of the circulatory, endocrine, neurological, digestive, respiratory, genitourinary, hematological, immunological, psychiatric, and metabolic disorders or any other disease that could interfere with the results of the study;

Abnormal screening or check-in laboratory values including inadequate renal and hepatic function as assessed by the investigator (eGFR <90 mL/min/1.73 m² calculated using CKD-EPI 2021 at screening, and total bilirubin, ALP, GGT, AST, and ALT outside normal range). A single repeat measurement is permitted for abnormal laboratory values for determining eligibility, at the discretion of the investigator.

Clinically significant abnormal physical examination, vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg; heart rate <50 bpm or >100 bpm; temperature 35.6°C to 37.7°C), ECG (QTcF >450ms for males and >470ms for females), or laboratory findings, as judged by the investigator. A repeat vital sign or ECG measurement, at the investigator's discretion, is acceptable for determining eligibility. Vital sign measurements may be repeated at Screening and/or Check-in, as required.

Participants with a history of specific allergies (such as urticaria, allergic asthma, etc.), or 2 or more types of allergens (such as drugs, foods such as milk and pollen), or allergies to any of soybeans, alcohol, eggs, or known allergies to components or analogues of this drug;

Trial design

Design model

Crossover

Treatments tested in this trial

  • apripitant and palonosetron injectable emulsion

    Drug

    This is the test product involved in this study.

  • palonosetron hydrochloride injection

    Drug

    This is the second reference drug involved in this study, named as R2.

  • apripitant injection (CINVANTI)

    Drug

    This is the first reference product, named as R1

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: apripitant and palonosetron injectable emulsionExperimental treatment 1 intervention
Group B: apripitant injection (CINVANTI)Active comparator 1 intervention
Group C: palonosetron hydrochloride injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area Under the Curve (AUC)

The AUC data will be presented by analyzing the concentration data of all completed participants using the SAS V9.4 software

Time frame
up to 10 weeks
2

Peak Plasma Concentration (Cmax)

The peak plasma concentration (Cmax) will be presented by analyzing the concentration data of all completed participants using SAS V9.4 software

Time frame
up to 10 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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