Trial Outcomes & Findings for Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions (NCT NCT00939692)
NCT ID: NCT00939692
Last Updated: 2013-07-16
Results Overview
The maximum or peak concentration that the drug reaches in the plasma
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Results posted on
2013-07-16
Participant Flow
Participant milestones
| Measure |
Torrent's Topiramate First, Then Topamax
For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.
|
Topamax First, Then Torrent's Topiramate
For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.
|
|---|---|---|
|
Period 1 - First Intervention - 5 Days
STARTED
|
13
|
13
|
|
Period 1 - First Intervention - 5 Days
COMPLETED
|
12
|
13
|
|
Period 1 - First Intervention - 5 Days
NOT COMPLETED
|
1
|
0
|
|
Period 2 - Second Intervent - 5 Days
STARTED
|
12
|
13
|
|
Period 2 - Second Intervent - 5 Days
COMPLETED
|
12
|
12
|
|
Period 2 - Second Intervent - 5 Days
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Torrent's Topiramate First, Then Topamax
For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.
|
Topamax First, Then Torrent's Topiramate
For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.
Followed by a 21 day washout period.
For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.
|
|---|---|---|
|
Period 1 - First Intervention - 5 Days
Withdrawal by Subject
|
1
|
0
|
|
Period 2 - Second Intervent - 5 Days
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions
Baseline characteristics by cohort
| Measure |
Torrent's Topiramate
n=13 Participants
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
|
Topamax
n=13 Participants
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
30.3 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
30.3 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 10.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
13 participants
n=4 Participants
|
26 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.The maximum or peak concentration that the drug reaches in the plasma
Outcome measures
| Measure |
Torrent's Topiramate
n=24 Participants
tablet containing 25 mg of topiramate
|
Topamax
n=24 Participants
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
265.96 ng/ml
Standard Deviation 105.09
|
260.04 ng/ml
Standard Deviation 85.05
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t)
Outcome measures
| Measure |
Torrent's Topiramate
n=24 Participants
tablet containing 25 mg of topiramate
|
Topamax
n=24 Participants
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
1.51 mcg*hr/mL
Standard Deviation 0.94
|
1.25 mcg*hr/mL
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.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 |
Torrent's Topiramate
n=24 Participants
tablet containing 25 mg of topiramate
|
Topamax
n=24 Participants
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
17796.46 ng·h/mL
Standard Deviation 3500.70
|
17770.47 ng·h/mL
Standard Deviation 3944.14
|
Adverse Events
Torrent's Topiramate
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Topamax
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Torrent's Topiramate
n=26 participants at risk
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
|
Topamax
n=26 participants at risk
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
|
|---|---|---|
|
General disorders
Dizziness
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
General disorders
Pain
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
General disorders
nausea
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
Additional Information
Walter A Parham
Gateway Medical Research, Inc.
Phone: (314) 663-4550
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER