Health TrialsbyHealthPanel

A Food Effect Study of QLS1410 in Healthy Chinese Adults

ConditionUncontrolled Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).

Males and females aged 18 to 55 years, inclusive.

Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m², inclusive, at screening.

Has a mean seated office systolic blood pressure (SBP) 110~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).

Disqualifiers

Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.

Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.

Use of systemic corticosteroids within 3 months prior to screening.

Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.

Trial design

Design model

Single group

Treatments tested in this trial

  • QLS1410

    Drug

    QLS1410 tablets

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: QLS1410 20mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUC0-∞

Time frame
0 to 96 hours
2

Area under the curve plasma concentration from time zero to Time of Last Quantifiable Concentration

Time frame
0 to 96 hours
3

Maximum observed plasma concentration

Time frame
0 to 96 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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