An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 15, 2016

Primary Completion Date

May 3, 2016

Study Completion Date

May 3, 2016

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Gemigliptin

A 7-day treatment period with gemigliptin 50 mg q.d., followed by a 5-day washout period; a 7 day treatment period with metformin 1000 mg twice a day followed by a 5-day washout period and a final 7-day treatment period with gemigliptin 50 mg q.d. + metformin 1000 mg twice a day

DRUG

Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day

A 7-day treatment period with gemigliptin 50 mg q.d. + metformin 1000 mg twice a day followed by a 5-day washout period; a 7-day treatment period with gemigliptin 50 mg q.d. followed by a 5-day washout period and a final 7-day treatment period with metformin 1000 mg twice a day

DRUG

Metformin

A 7-day treatment period with 1000 mg metformin twice a day followed by a 5-day washout period; a 7-day treatment period with gemigliptin 50 mg q.d.+ metformin 1000 mg twice a day followed by a 5-day washout period and a final 7-day treatment period with gemigliptin 50 mg q.d.

Trial Locations (1)

57740

Unidad de Farmacología Clínica de la Facultad de Medicina de la Universidad Nacional Autónoma de México, Nezahualcóyotl

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Universidad Nacional Autonoma de Mexico

OTHER

collaborator

LG Chem

INDUSTRY

lead

Stendhal Americas, S.A.

INDUSTRY

NCT03310749 - An Assessment of Pharmacokinetic Gemigliptin and Metformin Interactions in Healthy Mexican Volunteers | Biotech Hunter | Biotech Hunter