A two-way crossover study to compare two types of levothyroxine
Research type
Research Study
Full title
A two-way crossover study to compare the bioequivalence of two Levothyroxine formulations in healthy volunteers.
IRAS ID
168166
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Wockhardt UK Ltd
Eudract number
2014-004826-17
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
Hypothyroidism affects 15 in every 1,000 women and 1 in 1,000 men in the UK. The condition can also develop in children, around 1 in 3,500 4,000 babies is born with an underactive thyroid (called congenital hypothyroidism).
Treatment for hypothyroidism involves taking daily hormone replacement to raise thyroxine levels. Treatment is usually life long and left untreated, hypothyroidism can lead to complications, including heart disease, goitre, pregnancy problems and a life threatening condition called myxoedema coma (although this is very rare).
Wockhardt UK Ltd is currently seeking marketing authorisation for a Levothyroxine Oral Solution. The purpose of this study is therefore to compare the bioavailability of Levothyroxine from the test IMP (Levothyroxine Oral Solution (50 µg/5 mL)) with that from the reference IMP (Eltroxin® Oral Solution (100 µg/ 5mL)), when administered as a single 600 µg oral dose.
The study will be conducted in up to 26 subjects (2 cohorts of 13 subjects). Subjects will undergo a screening period, two treatment periods (each comprising in-patient dosing comprising 2 overnight stays (from Day -1 to Day 2), two out-patient assessment visits on Day 3 and Day 4 respectively) and a follow-up visit. Each treatment period will be separated by at least 35 days.
The population eligible to take part in the study are healthy male and female (non-pregnant/non-lactating with negative pregnancy test at the screening visit) subjects between 18 and 50 years of age.
REC name
Wales REC 2
REC reference
15/WA/0002
Date of REC Opinion
11 Feb 2015
REC opinion
Further Information Favourable Opinion