Lack of a chiral pharmacokinetic interaction between venlafaxine and nifedipine in healthy subjects phenotyped as normal CYP2D6, CYP2C19 and CYP3A metabolizers.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-35mxys

Enrollment

Unknown

Registered

2020-08-07

Start date

2010-01-30

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venlafaxine Hydrochloride, Nifedipine, Pharmacokinetics, Healthy Volunteers

Interventions

Ten healthy, male, adult patients (23-33 years) were investigated, automatically reported as white, with a body mass index (BMI) below 25 kg / m2 and with biochemical and hematological tests with norm

60 and 72 h after drug administration. In Phase 2, the volunteers were treated with a single oral dose of 40 mg of nifedipine (Oxcord®, Laboratórios Biossintéticos Ltda, São Paulo, Brazil) associated

60 and 72 h after the administration of drugs. The volunteers were monitored for blood pressure and heart rat

Drug

Procedure/surgery

G07.690.773.968

N04.452.706.477

Eligibility

Sex/Gender

Male

Age

18 Years to 33 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; male; adults (23-33 years old); self-reported as white, body mass index (BMI) of less than 25 kg/m2; biochemical and hematological parameters within healthy range;

Exclusion criteria

Exclusion criteria: Smoking volunteers; volunteer using drugs; volunteers with biochemical and hematological parameters registered abnormality;

Design outcomes

Primary

Measure	Time frame
It was expected to find an increase in the area under the curve (AUC) of venlafaxine in the healthy volunteers investigated, through the determination of venlafaxine in plasma samples from the healthy volunteers of the control and interaction groups and calculation of the pharmacokinetic parameters, from the finding of a variation of at least 40% of venlafaxine in the AUC of the group that received that did not receive nifedipine (control) and the group that received (interaction).	—

Measure

Time frame

It was expected to find an increase in the area under the curve (AUC) of venlafaxine in the healthy volunteers investigated, through the determination of venlafaxine in plasma samples from the healthy volunteers of the control and interaction groups and calculation of the pharmacokinetic parameters, from the finding of a variation of at least 40% of venlafaxine in the AUC of the group that received that did not receive nifedipine (control) and the group that received (interaction).

—

Secondary

Measure	Time frame
It is expected to obtain the other pharmacokinetic parameters (clearence, volume of distribution, half-life), by the determination of venlafaxine in plasma samples from the healthy control and interaction groups and calculation of pharmacokinetic parameters, from the finding of a variation of at least 40% of the AUC of the group that received and did not receive nifedipine (control) and the group that received (interaction).	—

Measure

Time frame

It is expected to obtain the other pharmacokinetic parameters (clearence, volume of distribution, half-life), by the determination of venlafaxine in plasma samples from the healthy control and interaction groups and calculation of pharmacokinetic parameters, from the finding of a variation of at least 40% of the AUC of the group that received and did not receive nifedipine (control) and the group that received (interaction).

—

Countries

Brazil

Contacts

Public ContactVera Lanchote

Faculdade de Ciências Farmacêuticas de Ribeirão Preto

lanchote@fcfrp.usp.br+551633154699

Outcome results

None listed

Source: REBEC (via WHO ICTRP)