Trial Outcomes & Findings for A Study of Cephalexin in Healthy Participants (NCT NCT02100826)
NCT ID: NCT02100826
Last Updated: 2015-05-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Results posted on
2015-05-27
Participant Flow
Participant milestones
| Measure |
Cephalexin Dosing Sequence AB
Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses.
|
Cephalexin Dosing Sequence BA
Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses.
|
|---|---|---|
|
Period 1 (7 Days)
STARTED
|
14
|
14
|
|
Period 1 (7 Days)
COMPLETED
|
14
|
14
|
|
Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (1 Day)
STARTED
|
14
|
14
|
|
Washout Period (1 Day)
COMPLETED
|
14
|
14
|
|
Washout Period (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (7 Days)
STARTED
|
14
|
14
|
|
Period 2 (7 Days)
COMPLETED
|
14
|
14
|
|
Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Cephalexin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=28 Participants
Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
|
|---|---|
|
Age, Continuous
|
31.2 Years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each periodPopulation: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
Outcome measures
| Measure |
Cephalexin (Test)
n=27 Participants
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
|
Cephalexin (Reference)
n=28 Participants
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
|
77.430 hour*microgram per milliliter(h*μg/mL)
Geometric Coefficient of Variation 13.594
|
76.374 hour*microgram per milliliter(h*μg/mL)
Geometric Coefficient of Variation 13.196
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each periodPopulation: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data
Outcome measures
| Measure |
Cephalexin (Test)
n=28 Participants
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
|
Cephalexin (Reference)
n=28 Participants
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
|---|---|---|
|
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
|
2.000 Hours
Standard Deviation 0.996
|
1.250 Hours
Standard Deviation 0.739
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each periodPopulation: All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
Outcome measures
| Measure |
Cephalexin (Test)
n=28 Participants
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
|
Cephalexin (Reference)
n=28 Participants
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
|
34.002 Microgram per milliliter(µg/ml)
Geometric Coefficient of Variation 23.571
|
33.522 Microgram per milliliter(µg/ml)
Geometric Coefficient of Variation 24.454
|
Adverse Events
Cephalexin (Test)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cephalexin (Reference)
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 |
Cephalexin (Test)
n=28 participants at risk
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
|
Cephalexin (Reference)
n=28 participants at risk
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.1%
2/28 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60