A study to assess the effect of Colesevelum HCL 3750 mg on absorption of Glipizide ER 20 mg in gut, in healthy human adult subjects

Phase 3

Completed

• Registration Number: CTRI/2009/091/000931
• Lead Sponsor: Daiichi Sankyo Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the PK parameters AUC0-inf, AUC0-t and Cmax for Glipizide ERTimepoint: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 18, 24, 30, 36, 48, 60 and 72

Secondary Outcome Measures

Name	Time	Method
- The secondary outcome will be the PK parameters AUC0-24, tmax, Kel, t1/2, V/F, and CL/F for Glipizide ER. <br/ ><br>- Safety and tolerability endpoints include physical examination findings, vital signs, 12-lead electrocardiograms (ECGs), adverse events (AEs), hematology, serum chemistry and urinalysis (UA). <br/ ><br>- Blood glucose monitoring after the dose of Glipizide ERTimepoint: -Pk timepoints - 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 18, 24, 30, 36, 48, 60 and 72 <br/ ><br>- vital signs examination - pre dose within 1 hour, post dose 2, 4, 6, 12, 24, 36, 48, 60 and check out <br/ ><br>- Blood glucose monitoring at 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 16, 24 and 48 hours