Three Times Daily Dosing of UT-15C

A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01746485

Enrollment

Registered

2012-12-11

Start date

2012-07-31

Completion date

2012-07-31

Last updated

2012-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Volunteers

Brief summary

To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Interventions

DRUGUT-15C

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects * aged 18-55 years of age; * weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and * weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.	6 days	Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2

Secondary

Measure	Time frame	Description
PK profile of UT-15C after a single 0.5mg dose on Day 1	1 day	Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026