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OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.

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ClinicalTrials.gov Identifier: NCT01842620
Recruitment Status : Completed
First Posted : April 29, 2013
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: Metformin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted from 13 Mar 2013 to 04 May 2013 at single center in Argentina.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 25 participants were enrolled in the study; however, one participant withdrew from the study before completing the two study periods. The remaining 24 participants were considered for the pharmacokinetic (PK) analyses.

Reporting Groups
  Description
OXEMET Then GLAFORNIL Eligible participants received single oral metformin (OXEMET) 1000 milligrams (mg) for one day in Treatment period 1 and was followed by 7 days washout period. Participants then received single oral metformin (GLAFORNIL) 500 mg twice daily (BID) for one day in Treatment period 2, followed by 7 days follow-up period. The two treatment periods were separated by a washout period of 7 days and participants received the study drugs in a randomized manner.
GLAFORNIL Then OXEMET Eligible participants received single oral metformin (GLAFORNIL) 500 mg BID for one day in Treatment period 1 and was followed by 7 days washout period. Participants then received single oral metformin (OXEMET) 1000 mg for one day in Treatment period 2, followed by 7 days follow-up period. The two treatment periods were separated by a washout period of 7 days and participants received the study drugs in a randomized manner.

Participant Flow for 3 periods

Period 1:   Period 1
    OXEMET Then GLAFORNIL   GLAFORNIL Then OXEMET
STARTED   13   12 
COMPLETED   12   12 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 

Period 2:   Washout Period
    OXEMET Then GLAFORNIL   GLAFORNIL Then OXEMET
STARTED   12   12 
COMPLETED   12   12 
NOT COMPLETED   0   0 

Period 3:   Period 2
    OXEMET Then GLAFORNIL   GLAFORNIL Then OXEMET
STARTED   12   12 
COMPLETED   12   12 
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
Total Population Eligible participants received single oral metformin (OXEMET) 1000 mg for one day and single oral metformin (GLAFORNIL) 500 mg BID for one day in each of the two treatment periods in a randomized manner. Participants had a washout period of 7 days between two treatment periods and were followed up to 7 days after the last dose of the study drug

Baseline Measures
   Total Population 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.8  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  40.0% 
Male      15  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      25 100.0% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h)   [ Time Frame: From 0 to 36 hours (h) ]

2.  Primary:   Geometric Means for Area Under Plasma Concentration Time Curve of the Study Drug (Oxemet) to the Reference Drug (Glafornail) Between Time Zero to Infinity (Inf) Over Period   [ Time Frame: From 0 to 36 h ]

3.  Primary:   Geometric Means for Maximum Plasma Concentration of the Study Drug (Oxemet) to the Reference Drug (Glafornail) From 0 to 36 h   [ Time Frame: From 0 to 36 h ]

4.  Secondary:   The Elimination Constant (Kel) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h   [ Time Frame: From 0 to 36 h ]

5.  Secondary:   Terminal Plasma Half-life (t1/2) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h   [ Time Frame: From 0 to 36 h ]

6.  Secondary:   Time to Reach Maximum Plasma Concentration (Tmax) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) Over Period   [ Time Frame: From 0 to 36 h ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01842620     History of Changes
Other Study ID Numbers: 117219
First Submitted: April 25, 2013
First Posted: April 29, 2013
Results First Submitted: March 16, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017