A single-center, randomized, double-blind, placebo-controlled, dose escalation study to observe the safety and efficacy of catalpol tablets in Chinese healthy subjects.

Phase 1

Recruiting

• Conditions: diabetes

• Registration Number: ITMCTR1900002878
• Lead Sponsor: The First Affiliated Hospital, Zhejiang University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent.
2. Aged 18 to 45 years old, both men and women;
3. Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg);
4. Subjects Can communicate well with the researchers and comply with the requirements of the entire study.

Exclusion Criteria

1. According to comprehensive physical examination and laboratory test, the researchers were not identified as healthy subjects;
2. Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and respiratory, metabolic, nervous system, (especially the spastic diseases such as epilepsy), chronic infectious and other major diseases;
3. Allergic constitution: the persons allergic to two or more medicines, food and pollen or rehmannia;
4. History of hypoglycemia;
5. Drug abusenicotine or alcohol test positive;
6. Faint at the sight of blood or needle;
7. Blood donation or a history of acute blood loss (more than 400 mL) in 3 month of the study;
8. Participating in other clinical trials within the past 3 months;
9. Subject took over 5 cigarettes or Equivalent amounts of tobacco products every day in the past 3 months.
10. Drug abuse history in past 5 years or had ever used drugs inpast 3 months before screening.
11. Within 2 years prior to screening has a history of alcohol abuse, that drinking more than 3 units of
12. Alcohol of a day and 21 units of alcohol a week (1 = 350 mL beer, 120 mL liqueur, 30mL alcohol or 150 mL wine) ;
13. Pregnant or nursing women; Fertile woman cannot take effective appropriate precautions in 3 months after the study;
14. Subjects with acute disease during screening period;
15. Used any medicine in the last 2 weeks;
16. Female subjects did not take non-drug contraceptive measures within 14 days before enrollment;
17. Unsuitable to participate in the trial considered by the researchers.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MTD;AUC0-t;Cmax;Adverse events;