PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial

NCT02294448 | Unknown Phase 1 DMC

• 1 other identifier: PopPK profile of Qishe Pill
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China), composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus, has been developed and spread in use into clinical settings in 2009. As individualization has become the trend of modern medicine, a personalized medicine of Qishe Pill should be documented and practiced with various patients according to the ancient TCM system, a classification of personalized constitution type, which has been established to determine predisposition and prognosis to diseases as well as therapy and life-style administration. Therefore, we describe the population pharmacokinetic profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of individualized and standardized Traditional Chinese Medicine into clinical practice.

Conditions

Individuality; Narrative Medicine

Keywords

Cervical radiculopathy; Neck pain; Qishe pill; raditional Chinese medicine; healthy Chinese subject; Population Pharmacokinetics; Personalized Medicine; Individualized Medicine

Outcome Measures

Primary Outcomes (45)

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  Dosing(0 hour)

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  15 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  30 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  45 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  60 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  90 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  120 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  150 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  180 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  240 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  360 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  480 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  600 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  720 min after dosing

• Plasma concentrations of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  1440 min after dosing

• Plasma concentration of Qishe Pill

  5 ml blood samples for pharmacokinetic analysis

  2160 min after dosing

• Plasma sampling of Qishe Pill for pharmacokinetic analysis

  5 ml blood samples for pharmacokinetic analysis

  2880 min after dosing

• Vital signs

  body temperature, heart rate and blood pressure

  Dosing(0 hour)

• Vital signs

  body temperature, heart rate and blood pressure

  180 min after dosing

• Vital signs

  body temperature, heart rate and blood pressure

  720 min after dosing

• Vital signs

  body temperature, heart rate and blood pressure

  1440 min after dosing

• Vital signs

  body temperature, heart rate and blood pressure

  2160 min after dosing

• Vital signs

  body temperature, heart rate and blood pressure

  2880 min after dosing

• ECG monitoring

  Electrocardiograms (ECGs)

  Dosing(0 hour)

• ECG monitoring

  Electrocardiograms (ECGs)

  180 min after dosing

• ECG monitoring

  Electrocardiograms (ECGs)

  720 min after dosing

• ECG monitoring

  Electrocardiograms (ECGs)

  1440 min after dosing

• ECG monitoring

  Electrocardiograms (ECGs)

  2160 min after dosing

• ECG monitoring

  Electrocardiograms (ECGs)

  2880 min after dosing

• Number of Participants with Adverse Events

  The investigators will assess all clinical AEs according to the Medical Dictionary for Regular Activities criteria, in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study drug.

  Day 1 of drug administration and blood sampling

• Number of Participants with Adverse Events

  The investigators will assess all clinical AEs according to the Medical Dictionary for Regular Activities criteria, in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study drug.

  Day 2 of drug administration and blood sampling

• Number of Participants with Adverse Events

  The investigators will assess all clinical AEs according to the Medical Dictionary for Regular Activities criteria, in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study drug.

  Day 3 of drug administration and blood sampling

• Number of Participants with Adverse Events

  Subjects will be requested to return to the study unit 4 d after drug administration and blood sampling for a follow-up visit.

  4 days after drug administration and blood sampling

• Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage

  The maximum plasma concentration

  4 days after drug administration and blood sampling

• Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage

  The maximum plasma concentration

  4 days after drug administration and blood sampling

• Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage

  The maximum plasma concentration

  4 days after drug administration and blood sampling

• The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in low dosage

  The time to maximum concentration

  4 days after drug administration and blood sampling

• The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in medial dosage

  The time to maximum concentration

  4 days after drug administration and blood sampling

• The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in high dosage

  The time to maximum concentration

  4 days after drug administration and blood sampling

• Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in low dosage

  The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.

  4 days after drug administration and blood sampling

• Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in medial dosage

  The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.

  4 days after drug administration and blood sampling

• Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in high dosage

  The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.

  4 days after drug administration and blood sampling

• The distribution volume (DF) of Qishe Pill in low dosage

  The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.

  4 days after drug administration and blood sampling

• The distribution volume (DF) of Qishe Pill in medial dosage

  The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.

  4 days after drug administration and blood sampling

• The distribution volume (DF) of Qishe Pill in high dosage

  The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.

  4 days after drug administration and blood sampling

Secondary Outcomes (2)

• Deep phenotyping with genomics and functional genomics approaches

  Dosing(0 hour)

• Deep phenotyping with genomics and functional genomics approaches

  2880 min after dosing

Other Outcomes (3)

• The Constitution in Chinese Medicine Questionnaire (CCMQ)

  During screening in the recuitment

• The Constitution in Chinese Medicine Questionnaire (CCMQ)

  2880 min after dosing

• Laboratory measures and clinical assessment

  During screening in the recuitment

Study Arms (3)

cohort 1

EXPERIMENTAL

Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg)

Drug: Qishe Pill

cohort 2

EXPERIMENTAL

Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg)

Drug: Qishe Pill

cohort 3

EXPERIMENTAL

Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg)

Drug: Qishe Pill

Interventions

Qishe Pill DRUG

Qishe Pill is a thin 0.15 g film-coated pill, composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus, which should be taken orally with water (240mL) after a minimum 10-hour fast

cohort 1; cohort 2; cohort 3

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20-35
• kg/m2 ≤Body mass index (BMI) \<23 kg/m2
• TCM-constitutionally typed as either the 3 major type

You may not qualify if:

• History of impaired fasting glucose or diabetes mellitus (past history of diabetes or fasting blood glucose at screening ≥100 mg/dl)
• History of liver disease (hepatitis, hepatic cirrhosis) or hepatic dysfunction (AST or ALT at screening ≥40 U/L)
• History of renal dysfunction (creatinine at screening ≥1.2 mg/dl)
• History of heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia)
• History of malignant tumor
• Having digestive disorders that can interfere with normal absorption of standard diet (gastritis, gastric ulcer, duodenitis, duodenal ulcer, etc.)
• Smoking during the recent 3 months
• Alcohol consumption 3 or more times a week during the recent 3 months
• Women who were pregnant, intended to become pregnant, or breast- feeding
• Medicated during the recent month for therapeutic or prophylactic purposes
• Participating in another clinical trial

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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MeSH Terms

Conditions

Narrative Medicine; Radiculopathy; Neck Pain

Interventions

qishe

Condition Hierarchy (Ancestors)

Narration; Communication; Behavior; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong-jun Wang, Dr.

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue-Jun Cui, Dr.

CONTACT

13917715524@139.com

Yue-li Sun, Dr

CONTACT

edisonlike2008@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CN (1)