NCT00684814

Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions

38 people

55.3%

44.7%

21 womenmiddle line = equal numbers17 men

Phase: PHASE1
Paid for by: Mutual Pharmaceutical Company, Inc.
Finished: 2004-05
Health conditions: Healthy
Who could join: Anyone
Ages: 18 Years – no maximum
Average age: mean 28.92 years
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 86.8% · Black / African American 13.2% · American Indian / Alaska Native 0% · Asian 0% · Native Hawaiian / Pacific Islander 0% · More than one race 0% · Not reported 0%

No pregnant women
Women who were pregnant could not join.
“Females who are pregnant or lactating.”
No breastfeeding moms
Women who were breastfeeding could not join.
“Females who are pregnant or lactating.”
Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“Smokers or subjects who use tobacco/nicotine products. Three months abstinence is required.”
No kidney or liver problems
Women with kidney or liver problems were turned away.
“History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.”
No diabetes
Women with diabetes were turned away.
“History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.”
No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“History of mental depression.”
No cancer
Women with current or past cancer were turned away.
“History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.”
No smokers
Women who smoke or use nicotine were turned away.
“Smokers or subjects who use tobacco/nicotine products. Three months abstinence is required.”

Study titles and rules are shown in their original English.