Trial Outcomes & Findings for Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions (NCT NCT00939536)
NCT ID: NCT00939536
Last Updated: 2013-10-22
Results Overview
The maximum or peak concentration that the drug reaches in the plasma
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.
Results posted on
2013-10-22
Participant Flow
healthy, normal subjects
Participant milestones
| Measure |
Ambien First, Then Torrent's Zolpidem
For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg
Followed by a 7 day washout period.
For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg.
|
Torrent's Zolpidem First, Then Ambien
For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.
Followed by a 7 day washout period.
For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
12
|
|
First Intervention
COMPLETED
|
12
|
12
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
12
|
|
Second Intervention
COMPLETED
|
12
|
12
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions
Baseline characteristics by cohort
| Measure |
Experimental
n=12 Participants
Torrent's Zolpidem Tartrate Tablets 10 mg
|
Active Comparator
n=12 Participants
Ambien® 10mg tablets
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
28.2 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
28.2 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.The maximum or peak concentration that the drug reaches in the plasma
Outcome measures
| Measure |
Experimental
n=24 Participants
Torrent's Zolpidem Tartrate Tablets 10 mg
|
Active Comparator
n=24 Participants
Ambien® 10mg tablets
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
177.69 ng/ml
Standard Deviation 57.05
|
172.64 ng/ml
Standard Deviation 72.15
|
PRIMARY outcome
Timeframe: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)
Outcome measures
| Measure |
Experimental
n=24 Participants
Torrent's Zolpidem Tartrate Tablets 10 mg
|
Active Comparator
n=24 Participants
Ambien® 10mg tablets
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
751.31 mcg*hr/mL
Standard Deviation 399.17
|
717.71 mcg*hr/mL
Standard Deviation 401.92
|
PRIMARY outcome
Timeframe: plasma samples were obtained from blood drawn at 0 (within 60 minutes prior to dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours (18 samples) after administration of the dose.The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Experimental
n=24 Participants
Torrent's Zolpidem Tartrate Tablets 10 mg
|
Active Comparator
n=24 Participants
Ambien® 10mg tablets
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
778.16 mcg*hr/mL
Standard Deviation 418.74
|
741.65 mcg*hr/mL
Standard Deviation 415.73
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Active Comparator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental
n=24 participants at risk
Torrent's Zolpidem Tartrate Tablets 10 mg
|
Active Comparator
n=24 participants at risk
Ambien® 10mg tablets
|
|---|---|---|
|
General disorders
vomiting
|
16.7%
4/24 • Number of events 4
|
—
0/0
|
|
General disorders
nausea
|
8.3%
2/24 • Number of events 2
|
—
0/0
|
|
General disorders
regurgitation of water content
|
8.3%
2/24 • Number of events 2
|
—
0/0
|
|
General disorders
giddiness
|
4.2%
1/24 • Number of events 1
|
—
0/0
|
Additional Information
Kedar Joshi
Accutest Research Laboratories Pvt. Ltd.
Phone: +91 22 27780718
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER