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The following 3 groups of patients should be compared: (1) patients with emesis gravidarum who take a chewing gum with vitamin C (verum) "ad libitum" several times daily for 2 weeks; (2.) patients with emesis gravidarum who take chewing gum without vitamin C (placebo) "ad libitum" several times
The investigational product will be administered using a delivery device comprised of: (a) a vial prefilled with DPI-386 Nasal Gel or placebo nasal gel, and (b) a nasal gel pump attached to the vial during the manufacturing process. Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the
Each subject eligible for the study on Day 0 will be assigned a subject number (starting with 101 for male subjects and 201 for female subjects) in consecutive order which will randomize the subject to one of the three study arms: double-blind DPI-386 Nasal Gel; double-blind placebo nasal gel; or
LAB VISIT #1: ORIENTATION AND BASELINE TESTING (about 1.5 hours):
One to two weeks prior to the start of the study, study participants will report to the NCRC Human Performance Lab for orientation and baseline testing. Study participants will be screened to verify "low risk" status for
The world health organisation has reported that over 220 million people suffer from diabetes worldwide and that by the year 2030, this number will be doubled. The WHO also reports that in 2004, about 3.4 million people died from high blood sugar. About 90% of all diabetes cases is due to type II
The secondary objectives of the study are to evaluate:
- Modification of gastric pH after administration of drugs by measuring with gastroesophageal pH Monitor, comparing the results between the groups;
- The incidence of administration of rescue medications, through the accounts of patients and