Pharmacokinetics, safety, and tolerability of saroglitazar (ZYH1), a predominantly PPARα Agonist with Moderate PPARγ Agonist activity in healthy human subjects
ABDOMINAL PAIN;
ADULT;
AREA UNDER THE CURVE;
ARTICLE;
BACKACHE;
BODY PAIN;
CALF PAIN;
COMMON COLD;
CONTROLLED STUDY;
COUGHING;
DIARRHEA;
DISEASE SEVERITY;
DIZZINESS;
DOSE RESPONSE;
DOUBLE BLIND PROCEDURE;
DRUG ABSORPTION;
DRUG BLOOD LEVEL;
DRUG DOSE ESCALATION;
DRUG ELIMINATION;
DRUG HALF LIFE;
DRUG SAFETY;
DRUG TOLERABILITY;
DYSPEPSIA;
ELECTROCARDIOGRAM;
FEMALE;
FEVER;
FOOD DRUG INTERACTION;
HEADACHE;
HUMAN;
LABORATORY TEST;
MALAISE;
MALE;
NAUSEA;
NORMAL HUMAN;
PAIN;
PHASE 1 CLINICAL TRIAL;
PRIORITY JOURNAL;
PRURITUS;
RANDOMIZED CONTROLLED TRIAL;
RASH;
SEX DIFFERENCE;
SIDE EFFECT;
SINGLE DRUG DOSE;
VITAL SIGN;
ADOLESCENT;
ADULT;
AREA UNDER CURVE;
DOSE-RESPONSE RELATIONSHIP, DRUG;
DOUBLE-BLIND METHOD;
FEMALE;
FOOD-DRUG INTERACTIONS;
HEALTHY VOLUNTEERS;
HUMANS;
MALE;
MIDDLE AGED;
PHENYLPROPIONATES;
PLACEBOS;
PPAR ALPHA;
PYRROLES;
SEX FACTORS;
YOUNG ADULT;
Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes
11587045 10.1007/PL00002934
Morrish NJ, Wang SL, Stevens LK, et al. Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia. 2001;44(Suppl 2):S14-21.
Combined effects of routine blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes in patients with type 2 diabetes
10.2337/dc09-0959
Sophia Z, Bastiaan EG, Toshiharu N, et al. Combined effects of routine blood pressure lowering and intensive glucose control on macrovascular and microvascular outcomes in patients with type 2 diabetes. Diabetes Care. 2009;32:2068-74.
Dyslipidemia management in adults with diabetes. Clinical Practice Recommendation 2004
American Diabetes Association
American Diabetes Association. Dyslipidemia management in adults with diabetes. Clinical Practice Recommendation 2004. Diabetes Care. 2004;27 (Suppl. 1):S68-71.
Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol; Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group
Rubins HB, Robins SJ, Collins D, et al. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol; Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med. 1999;341:410-8.
Effects of the dual peroxisome proliferator-activated receptor-α/γ agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY)
10.1016/S0140-6736(09)60870-9
Robert RH, Michael AL, Sunder M, et al. Effects of the dual peroxisome proliferator-activated receptor-α/γ agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY). Lancet. 2009;374:126-35.
US Food and Drug Administration US Department of Health and Human Services Accessed 10 Sep 2013
US Food and Drug Administration. Guidance for bioanalytical method validation, US Department of Health and Human Services. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070107.pdf. Accessed 10 Sep 2013.
