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Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

NCT02548806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-04-18

No results posted yet for this study

Summary

The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Clonidine MBT 50µg

Clonidine MBT 50µg, single dose

DRUG

Clonidine MBT 100µg

Clonidine MBT 100µg, single dose

DRUG

Catapres 100μg

Catapres tablet 100μg, single dose

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

  • Girish Sharma, MD · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02548806 on ClinicalTrials.gov