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A Study of Cephalexin Capsules in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02123446
Recruitment Status : Completed
First Posted : April 25, 2014
Results First Posted : May 27, 2015
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Intervention Drug: Cephalexin
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cephalexin Dosing Sequence AB Cephalexin Dosing Sequence BA
Hide Arm/Group Description 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. 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 Title: Period 1 (7 Days)
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Washout Period (1 Day)
Started 14 14
Completed 13 14
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Period Title: Period 2 (7 Days)
Started 13 14
Completed 13 14
Not Completed 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
30.4  (8.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
15
  53.6%
Male
13
  46.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
28
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 28 participants
28
1.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Hide Description [Not Specified]
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
Arm/Group Title Cephalexin (Reference) Cephalexin (Test)
Hide Arm/Group Description:
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
Overall Number of Participants Analyzed 25 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter(h*µg/mL)
19.102
(16.751%)
19.207
(17.551%)
2.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
Hide Description [Not Specified]
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.
Arm/Group Title Cephalexin (Reference) Cephalexin (Test)
Hide Arm/Group Description:
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
Overall Number of Participants Analyzed 25 25
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter(µg/ml)
10.976
(24.981%)
9.710
(39.223%)
3.Secondary Outcome
Title Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
Hide Description [Not Specified]
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had at least one study treatment and had evaluable PK data.
Arm/Group Title Cephalexin (Reference) Cephalexin (Test)
Hide Arm/Group Description:
Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
Overall Number of Participants Analyzed 25 25
Median (Standard Deviation)
Unit of Measure: hours
1.000  (0.765) 1.000  (0.876)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cephalexin (Reference) Cephalexin (Test)
Hide Arm/Group Description Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
All-Cause Mortality
Cephalexin (Reference) Cephalexin (Test)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cephalexin (Reference) Cephalexin (Test)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cephalexin (Reference) Cephalexin (Test)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02123446     History of Changes
Other Study ID Numbers: 15313
A3Q-ME-AFBP ( Other Identifier: Eli Lilly and Company )
First Submitted: April 23, 2014
First Posted: April 25, 2014
Results First Submitted: May 8, 2015
Results First Posted: May 27, 2015
Last Update Posted: July 15, 2015