Healthy Subjects Clinical Trial
Official title:
A Phase 1, Open-Label, Sequential Design Study to Evaluate the Potential Effect of Multiple Oral Doses of Extended-Release Combination of Naltrexone and Bupropion on the Pharmacokinetics of a Single Oral Dose of Metformin in Healthy Subjects
The purpose of this study is to determine the effect of multiple oral doses of naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.
The drug being tested in this study is naltrexone HCl and bupropion HCl Extended- Release
fixed dose combination (NB) . This study will evaluate the potential effect of multiple oral
doses of extended-release combination of naltrexone/bupropion on the PK of a single oral
dose of metformin in healthy participants with normal renal function (defined as creatinine
clearance [CrCl] greater than equal to [>=] 90 milliliter per minute [mL/min]/1.73 meter
square [m^2]).
The study will enroll approximately 30 participants. Participants will receive:
Metformin 850 mg as a single dose alone and in combination with multiple doses of
Naltrexone/Bupropion Naltrexone 8 mg/Bupropion 90 mg + Naltrexone 16 mg/Bupropion 180 mg as
multiple doses alone and in combination with a single dose of metformin
All participants will be asked to take 1 tablet of metformin in the morning on Day 1 and Day
14, 1 tablet of naltrexone/bupropion twice daily from Day 3 through Day 5, and 2 tablets of
naltrexone/bupropion twice daily from Day 6 through Day 15.
This single center trial will be conducted in the United States. The overall time to
participate in this study is 73 days. Participants will be admitted on Day -1 (check in) and
remain confined to the clinic until Day 16 and will be contacted by telephone 30 (±2) days
after last dose of study drug for a follow-up assessment. Serial blood samples will be
collected for PK assessments. Safety will be monitored throughout the study.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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