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Completed

NCT Number: NCT06164431

Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273

The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.

Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
  • Ability to understand and willingness to sign a written informed consent form;
  • Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion criteria

  • Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
  • Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening;
  • Smoking more than 5 cigarettes per day within 3 months prior to screening,or who cannot stop using any tobacco products during the study period;
  • Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
  • Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
  • Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
  • Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
  • Females who are pregnant, lactating, or likely to become pregnant during the study.
  • History of dysphagia or any gastrointestinal disorder that affect absorption

Treatment and study plan

ZSP1273 tablet

Drug

Participants receive ZSP1273 tablet orally.

zsp1273 granules

Drug

Participants receive ZSP1273 granules orally.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Day 1 to Day 20

    The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.

  2. Area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: Day 1 to Day 20

    The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.

  3. Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)

    Time frame: Day 1 to Day 20

    The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.

Secondary outcomes

  1. Number of participants with drug-related adverse events as assessed by CTCAE v5.0

    Time frame: Day 1 to Day 20

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

Single-dose, Open-label, Randomized, Crossover Bioavailability Study of 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 Under Fasted Condition in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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