Safety Evaluation of Aminophylline and Methazolamide
Condition: Mountain Sickness
MeSH terms: Altitude Sickness
Intervention: Aminophylline; Methazolamide; Aminophylline and Methazolamide
Intervention description: Aminophylline dosage form-tablet dosage-500mg; Methazolamide dosage form-tablet dosage-250mg; Aminophylline 500mg orally and Methazolamide 250mg orally
Intervention MeSH terms: Aminophylline; Methazolamide; Theophylline
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Altitude Sickness; High Altitude Sickness

Summary:

      This safety study is the first in a series of studies testing the application of the
      combination of aminophylline and methazolamide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 weighting at least 150 lbs. Women
             who are of childbearing potential, must, if sexually active, must agree to use
             appropriate contraceptive measures for the duration of the study and for one (1) month
             afterwards.

          -  Subjects must agree not to donate blood, plasma, platelets, or any other blood
             components during the study and for 4 weeks after the last dose.

        Exclusion Criteria:

          -  History or manifestation of clinically significant neurological, gastrointestinal,
             renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine,
             hematologic or other medical disorders.

          -  Serious mental or physical illness within the past year.

          -  History of clinically significant illness within 4 weeks prior to Day 1.

          -  History of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the
             products administered during the study, including allergy to any sulfa or sulfonamide
             derivatives.

          -  Use of any of the following:

          -  Any concomitant medication. 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.

          -  Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within
             the past two years.

          -  Positive results on screening tests for drugs of abuse, cotinine or alcohol at
             screening or the pre-dose assessment at check-in.

          -  Clinically significant ECG abnormality, in the opinion of the Investigator.

          -  Use of tobacco products or other nicotine-containing products (including smoking
             cessation aids, such as gums or patches) with in 14 days of screening and throughout
             hospitalization.

          -  Subjects of childbearing potential who are pregnant (as based on test results) or are
             breast feeding.

          -  Has taken any other investigational drug during the 30 days prior to the screening
             visit or is currently participating in another investigational clinical trial.

          -  Subjects who have made any significant donation (including plasma) or have had a
             significant loss of blood within 30 days prior to Period 1, Day 1.

        Receipt of a transfusion or any blood products within 30 days prior to Period 1, Day 1.