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Pharmacokinetics study of Relinqing granule and its interaction with ciprofloxacin in health volunteers

Pharmacokinetics study of Relinqing granule and its interaction with ciprofloxacin in health volunteers

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPh-16010029
Enrollment
Unknown
Registered
2016-11-28
Start date
2016-11-29
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

diseases of urinary system

Interventions

Group A:Single RLQ_PK
Group B:Multiple RLQ_PK
Group C:DDI_Ciprofloxacin
Group D:DDI_RLQ_multi +CIP
Group E:DDI_RLQ_single+CIP

Sponsors

Second affiliated hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: (1) Healthy subjects aged 18~35 years old, and the age difference should less than 10 years in the same batch; (2) Body weight should more than 50 kg, and BMI in range of 19~24kg/m2 [BMI=weight (kg)/height 2(m2)]; (3) General physical examination, laboratory examination, chest electrocardiogram and other physical and chemical inspection should be normal; (4) No history of major diseases, no smoking history of alcoholism, urine pregnancy test should be negative for childbearing age women; (5) Subject is able to communicate with investigator well and comply with requires of study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Participated in other clinical subjects within 3 months; (2) Blood donation in the last 1 month or intend to donate blood in the following 1 month; (3) Used any medicine in the last 2 weeks; (4) Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc; (5) The general examination and blood pressure, heart rate and respiratory conditions are not qualified; (6) Physical examination found that there are any significant clinical symptoms; (7) Laboratory test (hematology, urine analysis, blood biochemistry, ECG examination and the four markers) results judged as Heart, liver and kidney dysfunction; (8) Women in gestation period and lactation period, and menstrual period; (9) Allergic constitution: the persons allergic to two or more medicines, food and pollen or ingredients of investigator produc; (10) Drug abusers, tobacco and alcohol addiction; (11) Unsuitable to participate in the trial considered by the researchers.

Design outcomes

Primary

MeasureTime frame
protocatechuic acid in plasma;gallic acid in plasma;Ciprofloxacin in plasma;protocatechuic acid in urine;gallic acid in urine;

Countries

China

Contacts

Public ContactHuang Yuhong

Second affiliated hospital of Tianjin University of Traditional Chinese Medicine

hyh101@126.com+86 13012264994

Outcome results

None listed

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