Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers

NCT02096744 | Completed Phase 1 Results

• 1 other identifier: 253.2486
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h)

  AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration

• Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7)

  Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.

  1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration

Secondary Outcomes (2)

• AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity)

  1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration

• Cmax (Maximum Concentration of Clonidine in Plasma)

  1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration

Study Arms (3)

Catapres-TTS-3 crossover 1

EXPERIMENTAL

subject to receive 0.3 mg/24 hr Catapres-TTS-3 Oppanol (T1) first, followed by Catapres-TTS-3 Vistanex (R1)

Drug: Intervention 1: Catapres-TTS-3; Drug: Intervention 2: Catapres-TTS-3

Catapres-TTS-3 crossover 2

EXPERIMENTAL

subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex (R1) first, followed by Catapres-TTS-3 Oppanol (T1)

Drug: Intervention 1: Catapres-TTS-3; Drug: Intervention 2: Catapres-TTS-3

Catapres-TTS-1 crossover 1

EXPERIMENTAL

subject to receive 0.1 mg/24 hr Catapres-TTS-1 with Oppanol (T2) and Vistanex (R2) simultaneously

Drug: Catapres-TTS-1

Interventions

Catapres-TTS-1 DRUG

Catapres-TTS-1 Oppanol

Catapres-TTS-1 crossover 1

Intervention 1: Catapres-TTS-3 DRUG

Catapres-TTS-3 Oppanol

Catapres-TTS-3 crossover 1

Intervention 2: Catapres-TTS-3 DRUG

Catapres-TTS-3 Vistanex

Catapres-TTS-3 crossover 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age greater than or equal to 18 and Age less than or equal to 65 years
• BMI greater than or equal to 18.5 and BMI less than or equal to 32.0 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study
• Male subjects, or females who meet any of the following criteria from at least 30 days before the first study drug administration and until 30 days after trial completion:
• Using adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral contraceptives, intrauterine device (IUD)
• Sexually abstinent
• Have a vasectomised sexual partner (vasectomy at least one year prior to enrolment)
• Surgically sterilised (including hysterectomy)
• Postmenopausal defined as at least one year of spontaneous amenorrhea

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal
• Repeated measurement of supine systolic blood pressure outside the range of 100-140 mm Hg or diastolic blood pressure outside the range of 60-90 mm Hg or pulse less than 55 bpm
• Any subject with orthostatic hypotension at baseline screening exam
• Any laboratory value outside the reference range
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic (including insulin-dependent diabetes), immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders (such as depression) or neurological disorders (such as neuropathy)
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity
• Intake of drugs with a long half-life (greater than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
• Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Any concomitant therapy
• Smoker

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

253.2486.1 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2015-06

Locations

US (1)