NCT02981290

A Randomized, Open Label, Four-way Crossover Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Subjects

Completed Phase 1 Last updated 1 December 2016

What this trial tests

Phase 1 trial testing Renodapt in Healthy Volunteers in 32 participants. Completed in 1 October 2008.

Timeline

1 July 2008

Primary endpoint
1 October 2008

1 October 2008

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 July 2008
Primary completion	1 October 2008
Estimated completion	1 October 2008
Sites	1 location across New Zealand

Drugs / interventions tested

• Renodapt — full drug profile →
• Mycept — full drug profile →
• Cellmune — full drug profile →
• CellCept — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA
  Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of MPA
  Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
• Maximum Observed Plasma Concentration (Cmax) of MPA
  Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
• Time to Reach Maximum Observed Plasma Concentration (Tmax) of MPA
  Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
• Absorption Lag Time (Tlag) of MPA
  Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
• Plasma Terminal Half-Life (t1/2) of MPA
  Time frame: Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1

Sponsor's own description

This is a single center, randomized, open label, 4-treatment, 4-period, 4-sequence, 4-way crossover study to compare the pharmacokinetics of mycophenolate mofetil (MMF) metabolites from 4 tablet formulations in healthy participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil
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   Reigner B, Grange S, Bentley D, Banken L, et al · · 2019 · cited 8× · PMID 31397274 · DOI 10.5414/cp203487