Trials Sponsors Conditions Drugs Pricing

Conditions

High Altitude Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

Adverse Events
To assess the Number of Participants with Adverse Events after dosing, as a Measure of Safety and Tolerability
24 hours after dosing
Pharmacokinetic
To assess the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in combination. PK sample collections for plasma Theophylline and Bambuterol determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post dose
24 hours after dosing

Study Arms (2)

Theophylline

ACTIVE COMPARATOR

Drug: Theophylline and Bambuterol

Bambuterol

ACTIVE COMPARATOR

Drug: Theophylline and Bambuterol

Interventions

Theophylline and BambuterolDrug

Treatment 3: Theophylline, 300 mg plus Bambuterol, 20 mg

BambuterolTheophylline

Named ingredients in these interventions

Linked from the registry description. Each source intervention is retained as reported.

bambuterol
In: Theophylline and Bambuterol
Theophylline
In: Theophylline and Bambuterol

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Theophylline and Bambuterol
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subjects must give written informed consent to participation in the study prior to screening. Consent will be documented by the subject's dated signature
Subjects must be healthy non-smoking adult male and female volunteers between the ages of 18 and 40 years, with a BMI of 18-30 kg/m2 and weighing at least 68 kg. Subjects health status will be determined by the medical history, physical examination, vital signs, electrocardiogram, blood chemistry, hematology, and urinalysis performed at screening.

Sponsors & Collaborators

Duke University
Othercollaborator
Oslo University Hospital
Othercollaborator
Norwegian Armed Forces Medical Service

Study Sites (1)

Institute of Aviation Medicine, Norwegian Armed Forces Medica

Oslo, 0313, Norway

MeSH Terms

Conditions

Pulmonary edema of mountaineers

Interventions

Theophyllinebambuterol

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Trond-Eirik Strand, M.D., Ph.D.
Institute of Aviation Medicine, Norwegian Armed Forces Medical
PRINCIPAL INVESTIGATOR
Thies Schroeder, Ph.D.
Department of Radiation Oncology, Duke University Medical Center
STUDY DIRECTOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Director General

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

March 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Individuals meeting ANY ONE of the following criteria will be excluded from the study:
Subjects with laboratory results outside the normal range, if considered clinically significant by the Investigator. In addition, subjects must have a normal hematocrit and hemoglobin concentration and be ≥ 36% and ≥ 12.0 g/dL, respectively and plasma potassium concentration of at least 3.9 mmol/l.
A mental capacity that is limited to the extent that the subject cannot provide legal consent or understand information regarding the side effects of the study drug.
Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years.
Unwillingness or lack of ability to comply with the protocol, or to reside in the inpatient unit during the required time period, or to cooperate fully with the Principle Investigator and site personnel.
Use of any of the following:
Any concomitant medication including oral contraceptive hormones. Subjects who have received any prescribed or non-prescribed (over-the-counter \[OTC\]) systemic medication, topical medications, or herbal supplements within 14 days from Day 1. St. John's Wort (hypericin) must not have been taken for at least 30 days prior to Period 1, Day 1.
Any drugs, foods or substances known to be strong inhibitors or strong inducers of CYP enzymes (also known as cytochrome P450 enzymes); especially CYP 1A2, or Pgp within 30 days prior to Period 1, Day 1.
Clinically significant ECG abnormality in the opinion of the Investigator.
Vital signs or clinically significant laboratory values at the screening visit that in the opinion of the Investigator would make the subject an inappropriate candidate for the study.
Has taken any other investigational drug during the 30 days prior to the screening visit or is currently participating in another investigational clinical trial.
Made any significant donation (including plasma) or have had a significant loss of blood within 30 or 90 days prior to Period 1, Day 1.
History or manifestation of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematologic or other medical disorders.
Subjects who are carriers of the Hepatitis B surface antigen (HbsAg), Hepatitis C antibody, or HIV antibody.
Serious mental or physical illness within the past year.
+15 more criteria

The Safety Evaluation of Drug Combinations Against High Altitude Pulmonary Hypertension

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Theophylline

Bambuterol

Interventions

Named ingredients in these interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Theophylline

Bambuterol

Interventions

Named ingredients in these interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations