MP0008 and Minastrin: BA and food effect study

• Research type

  Research Study

• Full title

  An Open-Label, Randomized, 3-Period, 3-Way Crossover Study to Compare the Pharmacokinetics of Norethindrone (NE) and Ethinyl Estradiol (EE) Administered as an MP0008 Orally Disintegrating Tablet and Minastrin® 24 Fe Chewable Tablet and to Evaluate the Effect of a High-Fat/High-Calorie Meal on the Pharmacokinetics of NE and EE in Healthy Female Subjects

• IRAS ID

  1006327

• Contact name

  Herman Ellman

• Contact email

  herman.ellman@millicentpharma.com

• Sponsor organisation

  Millicent Pharma Limited

• Eudract number

  2022-002845-16

• Research summary

  The study is designed to provide comparative information between 2 formulations of a contraceptive pill. One is licensed (Minastrin 24 chewable tablet). The other is a new formulation (an orally dispersing tablet - MP0008). \nBlood samples will be taken to compare the amount of the contraceptive hormones that reach the blood circulation after single doses of each. MP0008 will be administered in 2 different ways during the trial (once under fasting state and the other after high fat/calorie meal). It is crossover study so each subject will act as their own control to help eliminating bias.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  22/LO/0682

• Date of REC Opinion

  10 Nov 2022

• REC opinion

  Further Information Favourable Opinion