Trial Outcomes & Findings for Cimetidine Biowaivers (NCT NCT01256879)
NCT ID: NCT01256879
Last Updated: 2019-08-28
Results Overview
pharmacokinetic exposure (ng\*hr/ml)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
0-10 hours
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Cimetidine
cimetidine 200mg total dose (single dose)
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
CimTest-A
|
25
|
|
Overall Study
CimTest-B
|
24
|
|
Overall Study
Sorbitol-free Cimetidine Solution
|
24
|
|
Overall Study
Commercial Cimetidine Solution
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cimetidine
cimetidine 200mg total dose (single dose)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Cimetidine Biowaivers
Baseline characteristics by cohort
| Measure |
Cimetidine
n=25 Participants
cimetidine 200mg total dose (single dose)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-10 hourspharmacokinetic exposure (ng\*hr/ml)
Outcome measures
| Measure |
Experimental: CimTest-A
n=24 Participants
cimetidine capsule with hydroxypropyl methylcellulose (HPMC), a type of filler
cimetidine: cimetidine 200mg total dose (single dose)
|
Experimental: CimTest-B
n=24 Participants
cimetidine capsule with magnesium stearate, a type of filler
cimetidine: cimetidine 200mg total dose (single dose)
|
Active Comparator: Sorbitol-free Cimetidine Solution
n=24 Participants
non-commercial cimetidine solution
cimetidine: cimetidine 200mg total dose (single dose)
|
Experimental: Commercial Cimetidine Solution
n=24 Participants
commercial cimetidine solution
cimetidine: cimetidine 200mg total dose (single dose)
|
|---|---|---|---|---|
|
AUC
|
3896 ng*hr/ml
Standard Error 181
|
3661 ng*hr/ml
Standard Error 186
|
3495 ng*hr/ml
Standard Error 183
|
3512 ng*hr/ml
Standard Error 193
|
Adverse Events
Experimental: CimTest-A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental: CimTest-B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Sorbitol-free Cimetidine Solution
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Commercial Cimetidine Solution
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: CimTest-A
n=25 participants at risk
cimetidine capsule with hydroxypropyl methylcellulose (HPMC), a type of filler
cimetidine: cimetidine 200mg total dose (single dose)
|
Experimental: CimTest-B
n=24 participants at risk
cimetidine capsule with magnesium stearate, a type of filler
cimetidine: cimetidine 200mg total dose (single dose)
|
Active Comparator: Sorbitol-free Cimetidine Solution
n=24 participants at risk
non-commercial cimetidine solution
cimetidine: cimetidine 200mg total dose (single dose)
|
Experimental: Commercial Cimetidine Solution
n=24 participants at risk
commercial cimetidine solution
cimetidine: cimetidine 200mg total dose (single dose)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
pain
|
4.0%
1/25 • Number of events 1 • 10 hours
|
0.00%
0/24 • 10 hours
|
0.00%
0/24 • 10 hours
|
0.00%
0/24 • 10 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place