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Table 3 Inclusion and exclusion criteria

From: Population pharmacokinetic modeling of the Qishe pill in three major traditional Chinese medicine-defined constitutional types of healthy Chinese subjects: study protocol for a randomized controlled trial

  Criteria
Inclusion - Aged 20 to 35
  - 18.5 kg/m2 ≤body mass index (BMI) <23 kg/m2
  - Traditional Chinese medicine (TCM)-constitutionally typed as one of the three major types
Exclusion - 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 three 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