Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants
NCT ID: NCT02981290
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2008-07-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Renodapt Then Mycept Then Cellmune Then CellCept
Participants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Renodapt
Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
Mycept
Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Cellmune
Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCept
CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Mycept Then CellCept Then Renodapt Then Cellmune
Participants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Renodapt
Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
Mycept
Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Cellmune
Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCept
CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Cellmune Then Renodapt Then CellCept Then Mycept
Participants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Renodapt
Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
Mycept
Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Cellmune
Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCept
CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCept Then Cellmune Then Mycept Then Renodapt
Participants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Renodapt
Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
Mycept
Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Cellmune
Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCept
CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Interventions
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Renodapt
Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
Mycept
Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Cellmune
Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCept
CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any evidence of gall bladder surgery, surgery of the gastro-intestinal tract or any other medical condition considered likely to affect drug absorption
* Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
* Any known history of clinically significant allergic reactions or drug hypersensitivity, especially hypersensitivity to MMF or mycophenolic acid (MPA)
* Any other ongoing concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participants
* Any prescribed or over-the-counter (OTC) medication, herbal medicine or dietary aid taken within 2 weeks before the first study drug dosing or within six times the elimination half-life of the medication before the first study drug dosing
18 Years
55 Years
MALE
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Christchurch Clinical Studies Trust
Christchurch, , New Zealand
Countries
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References
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Reigner B, Grange S, Bentley D, Banken L, Abt M, Hughes R, Scheubel E, Guentert TW. Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil . Int J Clin Pharmacol Ther. 2019 Oct;57(10):506-519. doi: 10.5414/CP203487.
Other Identifiers
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WP21980
Identifier Type: -
Identifier Source: org_study_id