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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 3 periods

Period 1:   Period 1 (7 Days)
    Cephalexin Dosing Sequence AB   Cephalexin Dosing Sequence BA
STARTED   14   14 
COMPLETED   14   14 
NOT COMPLETED   0   0 

Period 2:   Washout Period (1 Day)
    Cephalexin Dosing Sequence AB   Cephalexin Dosing Sequence BA
STARTED   14   14 
COMPLETED   13   14 
NOT COMPLETED   1   0 
Physician Decision                1                0 

Period 3:   Period 2 (7 Days)
    Cephalexin Dosing Sequence AB   Cephalexin Dosing Sequence BA
STARTED   13   14 
COMPLETED   13   14 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.4  (8.39) 
Gender 
[Units: Participants]
 
Female   15 
Male   13 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   28 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
Mexico   28 


  Outcome Measures

1.  Primary:   Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose   [ 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 ]

2.  Secondary:   Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin   [ 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 ]

3.  Secondary:   Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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