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Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers

NCT02096744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-07-16

Study results available
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Summary

To establish the bioequivalence and adhesion properties of transdermal clonidine prepared with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.

Conditions

  • Healthy

Interventions

DRUG

Catapres-TTS-1

Catapres-TTS-1 Oppanol

DRUG

Intervention 1: Catapres-TTS-3

Catapres-TTS-3 Oppanol

DRUG

Intervention 1: Catapres-TTS-3

Catapres-TTS-3 Oppanol

DRUG

Intervention 2: Catapres-TTS-3

Catapres-TTS-3 Vistanex

DRUG

Catapres-TTS-1

Catapres-TTS-1 Vistanex

DRUG

Intervention 2: Catapres-TTS-3

Catapres-TTS-3 Vistanex

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02096744 on ClinicalTrials.gov