Recruitment

Recruitment Status
Completed

Inclusion Criteria

Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
...
Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
Familiar with the cycle ergometer exercise methodology
Recreational athletes according to the american college of sports medicine (ACSM) definition

Exclusion Criteria

Liver and/or renal and/or vascular disease
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Alcohol and drug abuse as stated in the clinical trial manual
...
Liver and/or renal and/or vascular disease
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Alcohol and drug abuse as stated in the clinical trial manual
Known hypertension
Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
Smokers
Female volunteers taking oral or injectable contraceptives
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial
Pregnancy and/or lactation
Known hypercholesterolemia (moderate/severe)

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Inclusion Criteria

Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
...
Written inform consent according to good clinical practice (GCP) and local regulations
Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
Familiar with the cycle ergometer exercise methodology
Recreational athletes according to the american college of sports medicine (ACSM) definition

Exclusion Criteria

Liver and/or renal and/or vascular disease
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Alcohol and drug abuse as stated in the clinical trial manual
...
Liver and/or renal and/or vascular disease
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Alcohol and drug abuse as stated in the clinical trial manual
Known hypertension
Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
Smokers
Female volunteers taking oral or injectable contraceptives
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial
Pregnancy and/or lactation
Known hypercholesterolemia (moderate/severe)

Tracking Information

NCT #
NCT02182934
Collaborators
Not Provided
Investigators
Not Provided