Trial Outcomes & Findings for A Study of Cephalexin Liquid in Healthy Participants (NCT NCT02490670)
NCT ID: NCT02490670
Last Updated: 2016-10-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period
Results posted on
2016-10-26
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).
|
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).
|
|---|---|---|
|
Period 1 (19 Days)
STARTED
|
14
|
14
|
|
Period 1 (19 Days)
COMPLETED
|
14
|
14
|
|
Period 1 (19 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (7 Days)
STARTED
|
14
|
14
|
|
Washout Period (7 Days)
COMPLETED
|
14
|
14
|
|
Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Period 2 (19 Days)
STARTED
|
14
|
14
|
|
Period 2 (19 Days)
COMPLETED
|
14
|
14
|
|
Period 2 (19 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Cephalexin Liquid in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cephalexin Dosing Sequence AB
n=14 Participants
Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).
|
Cephalexin Dosing Sequence BA
n=14 Participants
Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 Years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
25.36 Years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
27.18 Years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each periodPopulation: All randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cephalexin (Reference)
n=28 Participants
Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
Cephalexin (Test)
n=28 Participants
Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose
|
38.038 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 15.596
|
37.913 hour*microgram per milliliter (h*μg/mL)
Geometric Coefficient of Variation 14.071
|
PRIMARY outcome
Timeframe: Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each periodPopulation: All randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Cephalexin (Reference)
n=28 Participants
Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
Cephalexin (Test)
n=28 Participants
Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose
|
13.634 Microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 19.044
|
13.636 Microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 22.082
|
Adverse Events
Cephalexin (Reference)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cephalexin (Test)
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 (Reference)
n=14 participants at risk
Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
|
Cephalexin (Test)
n=14 participants at risk
Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
|
|---|---|---|
|
Cardiac disorders
hypotension
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/14
|
7.1%
1/14 • 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