NCT00939536
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
See it on ClinicalTrials.gov ↗24 people
33.3%
66.7%
8 womenmiddle line = equal numbers16 men
- Phase
- PHASE1
- Paid for by
- Torrent Pharmaceuticals Limited
- Finished
- 2005-07
- Health conditions
- Healthy
- Who could join
- Anyone
- Ages
- 18 Years – 45 Years
- Average age
- mean 28.2 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
- Not reported
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 45 Years.”
- No pregnant women
Women who were pregnant could not join.
“Pregnant and lactating women.”
- No breastfeeding moms
Women who were breastfeeding could not join.
“Pregnant and lactating women.”
- No hormonal birth control
Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.
“…measures, from the date of screening till the completion of the second period of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable. Use of hormonal contraceptives either oral or implants will not be acceptable.”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“History of psychiatric disorder or history of suicide attempt.”
- No cancer
Women with current or past cancer were turned away.
“History of malignancy or other serious diseases.”
- No smokers
Women who smoke or use nicotine were turned away.
“Refusal to abstain from smoking or consumption of tobacco products 24 hours before dosing until last sample collection of each period. Habituation of tobacco necessitating uninterrupted tobacco consumption.”
Study titles and rules are shown in their original English.