Trial Outcomes & Findings for Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions (NCT NCT00939705)
NCT ID: NCT00939705
Last Updated: 2011-10-10
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 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
2011-10-10
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
|
9
|
9
|
|
Period 1 - First Intervention - 5 Days
COMPLETED
|
9
|
9
|
|
Period 1 - First Intervention - 5 Days
NOT COMPLETED
|
0
|
0
|
|
Period 2 - Washout Period - 21 Days
STARTED
|
9
|
9
|
|
Period 2 - Washout Period - 21 Days
COMPLETED
|
9
|
9
|
|
Period 2 - Washout Period - 21 Days
NOT COMPLETED
|
0
|
0
|
|
Period 3 - Second Intervent - 5 Days
STARTED
|
9
|
9
|
|
Period 3 - Second Intervent - 5 Days
COMPLETED
|
9
|
9
|
|
Period 3 - Second Intervent - 5 Days
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Torrent's Topiramate
n=9 Participants
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
|
Topamax
n=9 Participants
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
|
Total
n=18 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
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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
|
32.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 10.8 • 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
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 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.Population: Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Torrent's Topiramate
n=396 blood samples
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
|
Topamax
n=396 blood samples
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
270.31 ng / ml
Standard Deviation 100.30
|
248.46 ng / ml
Standard Deviation 85.69
|
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.Population: Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.
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=396 blood samples
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
|
Topamax
n=396 blood samples
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
13762.05 ng h / ml
Standard Deviation 4003.49
|
13152.04 ng h / ml
Standard Deviation 3478.45
|
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.Population: Pharmacokinetic analyses are based on 18 out of 18 enrolled subjects who completed this study.
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=396 blood samples
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
|
Topamax
n=396 blood samples
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
|
|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
19689.88 ng h / ml
Standard Deviation 5889.87
|
18088.71 ng h / ml
Standard Deviation 4390.57
|
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: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Torrent's Topiramate
n=18 participants at risk
tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
|
Topamax
n=18 participants at risk
tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
|
|---|---|---|
|
General disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
|
Cardiac disorders
Intermediate Hypotension
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
0.00%
0/18 • 1 month
18 out of 18 enrolled subjects completed this study.
|
|
Skin and subcutaneous tissue disorders
Hematoma (Right Arm)
|
0.00%
0/18 • 1 month
18 out of 18 enrolled subjects completed this study.
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/18 • 1 month
18 out of 18 enrolled subjects completed this study.
|
5.6%
1/18 • Number of events 1 • 1 month
18 out of 18 enrolled subjects completed this study.
|
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