Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-30 @ 9:11 PM
Study NCT ID:
NCT02279667
Status:
COMPLETED
Last Update Posted:
2015-01-01
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single centre, open-label, randomised, three-way crossover study in 18 healthy subjects (9 males and 9 females). The study consisted of three consecutive single-dose treatment periods separated by a washout period of 7 days or more. On each treatment period, the volunteers received a single dose of BIA 2-093 800 mg, orally.
Detailed Description:
Sample size (planned and analyzed): It was planned to have at least 16 healthy subjects completed and evaluable. Taking into account the potential occurrence of dropouts, two additional subjects were to be recruited and entered the study. Therefore, a total of 18 subjects were enrolled.
Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.
Diagnosis and main selection criteria: Healthy male or female volunteers aged between 18 and 45 years, with body mass index between 19 and 28 kg/m2, non-smokers or smoking less than 10 cigarettes or equivalent per day.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: