Tolerability of Asasantin in Healthy Female and Male Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Asasantin ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT02269228

9.131

Details and patient eligibility

About

To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 %
• Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.

Exclusion criteria

• Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance
• Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
• Subjects with known history of orthostatic hypotension, fainting spells or blackouts
• Subjects with chronic or relevant acute infections
• Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Subjects who have taken a drug with a long half-life (> 24 hours) (≤ 1 month prior to administration or during the trial)
• Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
• Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)
• Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day
• Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food
• Subjects who drink more than 60 g of alcohol per day
• Subjects who are dependent on drugs
• Subjects who have donated blood (> 400 ml) (≤ 4 weeks prior to administration or during the trial)
• Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial)

For female subjects:

• Pregnancy
• Positive pregnancy test
• No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms)
• Inability to maintain this adequate contraception during the whole study period
• Lactation period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 3 patient groups, including a placebo group

Asasantin ER

Experimental group

Description:

Administered once daily (days 1 to 7), followed by twice daily administration (days 8 to 14)

Treatment:

Drug: Asasantin ER

Asasantin ER, administered twice daily from day 1 to day 14

Experimental group

Treatment:

Drug: Asasantin ER

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo