Rapid Acclimatization to Hypoxia at Altitude
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 09/30/2014 |
| Pirmasis pateikimas: | 10/02/2012 |
| Numatytas registravimas pateiktas: | 10/03/2012 |
| Pirmas paskelbtas: | 10/04/2012 |
| Paskutinis atnaujinimas pateiktas: | 10/22/2014 |
| Paskutinis atnaujinimas paskelbtas: | 10/23/2014 |
| Pirmųjų rezultatų pateikimo data: | 08/20/2014 |
| Pirmojo QC rezultatų pateikimo data: | 10/22/2014 |
| Pirmųjų paskelbtų rezultatų data: | 10/23/2014 |
| Faktinė studijų pradžios data: | 05/31/2012 |
| Numatoma pirminio užbaigimo data: | 11/30/2012 |
| Numatoma studijų užbaigimo data: | 11/30/2012 |
Būklė ar liga
Intervencija / gydymas
Drug: Placebo
Drug: Aminophylline
Drug: Methazolamide
Drug: Aminophylline+Methazolamide
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Placebo Comparator: Placebo Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.
Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions. | Drug: Placebo Yellow corn meal in gel capsules |
| Active Comparator: Aminophylline Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions. | Drug: Aminophylline National Drug Code (NDC) 0143-1020-01 |
| Active Comparator: Methazolamide Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. | Drug: Methazolamide NDC 0781-1072-01 |
| Active Comparator: Aminophylline+Methazolamide Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions. | Drug: Aminophylline+Methazolamide NDC 0143-1020-01 and NDC 0781-1072-01 |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - normotensive (i.e. <140/90 mmHg) Exclusion Criteria: - Pregnancy - nursing mother - current tobacco use or regular use within the previous two years - use of prescription medication other than birth control - asthma or any other type of lung/respiratory dysfunction - resting oxygen saturation <95% - unwillingness to abstain from exercise for 48 hours prior to laboratory testing - use of anticoagulant therapy or have a known or suspected bleeding disorder - identification of contraindication during screening (i.e. positive stress test) - any history of mountain sickness (altitude sickness) - any 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 - history of clinically significant illness within 4 weeks prior to Day 1 - Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to visit 1 - receipt of a transfusion or any blood products within 30 days prior to visit 1. |
Rezultatas
Pirminės rezultatų priemonės
1. Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen). [The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia]
