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To Evaluate the Safety, Tolerability, Pharmacokinetics and the Effect of Food on the Hemay5259 Sustained-release Tablets in Healthy Subjects.

ConditionPharmacokinetics
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHemay Pharmaceutical PTY. LTD.

About this trial

Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.

Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.

Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.

Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis).

Disqualifiers

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric , systemic, ocular, or infectious disease, or signs of acute illness.

Any history or presence of depression.

Any history or presence of gastrointestinal, hepatic, renal disease that affect drug absorption or metabolism.

Any surgery within 1 months prior to the first dose.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hemay5259 group 1

    Drug

    Food influence test: single administration of the drug, multiple dosing trial: administration once daily

  • placebo group 1

    Drug

    Food effect trial: single administration of the drug, multiple dosing trial: administration once daily

  • Hemay5259 group 2

    Drug

    Food influence test: single administration of the drug, multiple dosing test: administration once daily

  • Placebo group 2

    Drug

    Food influence test: single administration of the drug, multiple dosing test: administration once daily

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Hemay5259 group 1Experimental treatment 1 intervention
Group B: Placebo group 1Placebo comparator 1 intervention
Group C: Hemay5259 group 2Experimental treatment 1 intervention
Group D: Placebo group 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics (PK) of Hemay5259: Maximum plasma concentration (Cmax)in Part 1 and Part 2

Time frame
Day1-Day4，Day10-Day22
2

Pharmacokinetics (PK) of Hemay5259: Area under the curve from time 0 to the last measurable concentration (AUC0-last) in single dose and Multiple dose

Time frame
Day1-Day4，Day10-Day22
3

Pharmacokinetics (PK) of Hemay5259: Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)single dose and Multiple dose

Time frame
Day1-Day4，Day10-Day22
4

Pharmacokinetics (PK) of Hemay5259:time to Cmax (Tmax) in single dose and Multiple dose

Time frame
Day1-Day4，Day10-Day22

Secondary outcomes

1

Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion

This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.

Time frame
through study completion, an average of 1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hemay Pharmaceutical PTY. LTD.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: