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Pharmacokinetics Study of Qiliqiangxin Capsule in Healthy Subjects: An Open, Single-center, Single Dose Study

Pharmacokinetics Study of Qiliqiangxin Capsule in Healthy Subjects: An Open, Single-center, Single Dose Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008504
Enrollment
Unknown
Registered
2016-05-20
Start date
2016-05-03
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic heart failure

Interventions

treatment group:Qili Qiangxin Capsule 12 granules, po for once.

Sponsors

Hebei Yiling Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: (1) Healthy volunteers, male, aged 18 to 35 years, Han Nationality, Chinese; (2) The weight of all subjects must be greater than 50 kg; BMI does not exceed 15% of the ideal value. BMI = weight (kg) / height2 (m2) (BMI between 18.5 to 24.9); (3) General physical examination and laboratory, physical and chemical tests showed no significant disease or clinically significant abnormal findings; (4) According to GCP regulations, to obtain Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1) Primary diseases in heart, liver and kidney; history of digestive diseases, metabolic diseases or neurological diseases; 2) Psychiatric and somatic disabilities; 3) Clinically abnormalities in physical examination, biochemistry, routine blood/urine/stool test, ECG, chest x-ray or ultrasonography; 4) History of drug dependence, drug abuse or alcoholic poisoning; 5) Atopic subjects or subjects known to be allergic to Qiliqiangxin capsule or its components (including allergic reactions to other drugs); 6) Food or drink that may affect the metabolic enzyme activity of the drug, including alcohol, cocaine or orange, within 1 day of treatment; 7) Use drugs that are known to damage certain organ within 3 months; Use any drugs within 2 weeks; participate clinical trials with other investigational drugs within 4 weeks; 8) Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; heart rate 100 bpm); 9) Frequently drink alcohol within 6 months before treatment, that is drink more than 14 units every week (1 unit = 360 ml beer or 45 ml 40% alcohol or 150 ml wine); smoke more than 1 cigarette daily within 3 months before treatment; 10) Take soft drugs (marijuana) within 3 months or hard drugs (cocaine, phencyclidine) with 1 year before treatment; (11) Other possible factors may influence absorption, distribution, metabolism and excretion of drug; (12) Donate blood in the last three months; (13) According to the judgment of the investigator, the subject is not eligible (such as weakness, etc.).

Design outcomes

Primary

MeasureTime frame
Cmax;Tmax;AUC0-8;AUC0-t;t1/2;CL;

Countries

China

Contacts

Public ContactZhunhua Jia

Hebei Yiling Hospital

jiatcm@163.com+86 18503210608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026