Assessing the mechanisms of action of a bi-layer tablet containing calcium carbonate antacid
Research type
Research Study
Full title
An open label, single center, randomized, two-way crossover parallel group, trial to assess the mechanism of action of a bi-layer swallowable tablet (immediate release and sustained release) containing calcium carbonate antacid in an overnight and day application as compared with a standard, non-layered (immediate release) calcium carbonate swallow tablet in fed healthy male participants.
IRAS ID
1008466
Contact name
Gregor Bieri
Contact email
Sponsor organisation
Bayer Consumer Care AG
Research summary
This is an open label, single-centre, (night-time vs daytime) trial in up to 16 healthy male volunteers aged 18-65 years (inclusive).
The study will assess stomach acid levels, stomach retention time, and dispersion of a bi-layer swallowable tablet (immediate release and sustained release) calcium carbonate antacid in an overnight and during the day treatment as compared with a standard (non-layered) calcium carbonate swallowable tablet comparator.The following treatments will be dosed as part of this study:
-Bi-layer calcium carbonate tablet ( two tablets each containing 700mg of calcium carbonate; 325mg in the immediate release layer and 375mg in the sustained release layer)
-Immediate release calcium carbonate tablet ( two tablets each containing 700mg of calcium carbonate)Tablets will be administered orally with 240ml of non carbonated water .
The sustained release layer of one of the bilayer tablets and one of the immediate release comparator tablet administered at a dosing visit will be radiolabelled with approximately 4MBq 99mTc-DTPA. The gastrointestinal transit and release behaviour of the tablets will be studied using gamma scintigraphy. Images will be taken at set times as stated in the protocol. Stomach pH monitoring will be performed using a pH recorder and probe. The pH will be recorded at 10 second intervals from insertion of probe until 10h post dose.
Participants will visit the site on 4 occasions; a Screening Visit, a Treatment Phase (night-time sequence or day-time sequence) with two Treatment Visits, and a Follow-Up Visit. The first treatment administration will occur within 28 days of screening. At each treatment visit participants will be dosed with a single dose of the IMP. The two IMP administrations are separated by a least 6-8 day wash-out phase . The follow up will take place within 7-14 days of the last treatment visit.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0870
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion