Trial Outcomes & Findings for Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products (NCT NCT02010632)
NCT ID: NCT02010632
Last Updated: 2015-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
Results posted on
2015-05-04
Participant Flow
Participant milestones
| Measure |
Generic Clopidogrel Product
Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
Original Clopidogrel Product
Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
16
|
16
|
|
First Intervention (7 Days)
COMPLETED
|
16
|
16
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Wash Out Period (14 Days)
STARTED
|
16
|
16
|
|
Wash Out Period (14 Days)
COMPLETED
|
16
|
16
|
|
Wash Out Period (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
16
|
16
|
|
Second Intervention (7 Days)
COMPLETED
|
15
|
16
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Generic Clopidogrel Product
Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
Original Clopidogrel Product
Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
|---|---|---|
|
Second Intervention (7 Days)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparative Pharmacodynamics and Pharmacokinetics Study of Generic and Reference Clopidogrel Products
Baseline characteristics by cohort
| Measure |
All Study Participants
n=31 Participants
First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.43 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
31 participants
n=5 Participants
|
|
BMI
|
22.12 kg/m^2
STANDARD_DEVIATION 2.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7Outcome measures
| Measure |
Generic Clopidogrel Product
n=31 Participants
Apolets® 75 mg tablet
Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
Original Clopidogrel Product
n=31 Participants
Plavix® 75mg tablet
Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days
-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
|
|---|---|---|
|
Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)
|
1853.58 percent inhibition*hour
Standard Deviation 673.95
|
1892.84 percent inhibition*hour
Standard Deviation 657.22
|
SECONDARY outcome
Timeframe: Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7Outcome measures
Outcome data not reported
Adverse Events
Generic Clopidogrel Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Original Clopidogrel Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place