Rapid Acclimatization to Hypoxia at Altitude
Cuvinte cheie
Abstract
Datele
| Ultima verificare: | 09/30/2014 |
| Primul depus: | 10/02/2012 |
| Inscriere estimată trimisă: | 10/03/2012 |
| Prima postare: | 10/04/2012 |
| Ultima actualizare trimisă: | 10/22/2014 |
| Ultima actualizare postată: | 10/23/2014 |
| Data primelor rezultate transmise: | 08/20/2014 |
| Data primelor rezultate QC trimise: | 10/22/2014 |
| Data primelor rezultate postate: | 10/23/2014 |
| Data actuală de începere a studiului: | 05/31/2012 |
| Data estimată de finalizare primară: | 11/30/2012 |
| Data estimată de finalizare a studiului: | 11/30/2012 |
Stare sau boală
Intervenție / tratament
Drug: Placebo
Drug: Aminophylline
Drug: Methazolamide
Drug: Aminophylline+Methazolamide
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| 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 |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | 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. |
Rezultat
Măsuri de rezultate primare
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]
