NCT00833937
Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions
See it on ClinicalTrials.gov ↗24 people
12.5%
87.5%
3 womenmiddle line = equal numbers21 men
- Phase
- PHASE1
- Paid for by
- Teva Pharmaceuticals USA
- Finished
- 2002-03
- Health conditions
- Healthy
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- Not reported
- Age 65+
- 0%
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 66.7% · Black / African American 25% · Hispanic / Latina 8.3%
Women left out
- No pregnant women
Women who were pregnant could not join.
“Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reli…”
- No breastfeeding moms
Women who were breastfeeding could not join.
“Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reli…”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.”
- No hormonal birth control
Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.
“…ill not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to parti…”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“…icant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.”
- No diabetes
Women with diabetes were turned away.
“…icant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.”
- No seizures
Women with epilepsy or past seizures were turned away.
“…icant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…icant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.”
- No smokers
Women who smoke or use nicotine were turned away.
“Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.”
Study titles and rules are shown in their original English.