An open-label, randomized, 3-way crossover study to assess the effect of Colesevelam HCl (WelcholÂ®) 3750 mg on the single dose pharmacokinetics of Glipizide ER 20 mg in healthy human adult subjects

Daiichi Sankyo Pharma0 个研究点目标入组 42 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and female subjects, 18 to 45 years of age and body mass index (BMI) of 18 to 30 kg/m2
•2. Females who are non-childbearing potential
•3. Females who are of childbearing potential, must use an acceptable method of contraception
•4. Males should use an acceptable method of contraception
•5. Subjects must agree not to donate blood or blood components
•6. Subjects must be in good health as determined by the medical history, physical examination, vital signs, electrocardiogram, blood chemistry, hematology, and urinalysis performed at screening
•8. Subjects must give written informed consent to participate in the study prior to screening
•9. Subjects must be able to comply with the protocol and the assessments therein

•1. History of drug and alcohol abuse
•2. Subjects who have a history or presence of bowel obstruction
•3. Subjects with past history of and/or presence of hypertriglyceridemia-induced acute pancreatitis
•4. Subjects with past history of and/or diabetes mellitus
•5. Hypersensitivity to Glipizide ER or Colesevelam
•6. Any clinically significant medical history
•7. Any major surgical procedure
•8. Subjects who tested positive at screening for HIV, HbsAg or HCV
•9. Subjects with laboratory results outside the normal range, if considered clinically significant by the Investigator
•10. Subjects who need any concomitant medication
•11. Use of any prescription drug within 14 days of study initiation or any non prescription drug
•12. Use of any drugs or substances known to be strong inducers or inhibitors of CYP enzymes
•13. Subjects who consumed or did not agree to abstain from grapefruit and grapefruit juice
•14. Participation in a clinical study within 30 days of dosing
•15. Subjects having fasting plasma glucose level of less than 70 mg/dL at screening; and on check in
•16. Hemoglobin 12 g/dL at Screening
•17. Female is pregnant
•18. Subjects who, in the opinion of the Investigator, should not participate in the study
•19. Subjects who are employed by the CPU
•20. Subjects who have a familial relationship with another study participant

发起方

Daiichi Sankyo Pharma