---
title: Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers
nct_id: NCT02273518
overall_status: COMPLETED
phase: PHASE1
sponsor: Boehringer Ingelheim
study_type: INTERVENTIONAL
primary_condition: Healthy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02273518.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02273518"
ct_last_update_post_date: 2014-10-24
last_seen_at: "2026-05-12T06:05:29.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers

**Official Title:** A Double-blind, Randomised, 3-way Cross-over Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin ER Extended Release (ER) 200 mg Dipyridamole/25 mg ASA Formulations in Healthy Male and Female Volunteers

**NCT ID:** [NCT02273518](https://clinicaltrials.gov/study/NCT02273518)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Boehringer Ingelheim
- **Conditions:** Healthy
- **Start Date:** 2001-04
- **CT.gov Last Update:** 2014-10-24

## Brief Summary

Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* All participants in the study should be healthy males or females, range from 21 to 50 years of age and be within ± 20 % of their normal weight (Broca-Index)
* Prior to admission to the study all volunteers will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent
* Subsequently each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead ECG
* Hematopoietic, hepatic and renal function tests will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations
* The above mentioned examinations will be performed within 14 days before the first administration of the test substance

Exclusion Criteria:

* Volunteers are excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* 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 or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Subjects with chronic or relevant acute infections
* Subjects with allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Volunteers who have taken a drug with a long half-life (≥ 24 hours) within one month or less than ten half-lives of the respective drug before enrolment in the study
* Volunteers who receive any other drugs which might influence the results of the trial during the week previous to enrolment in the study
* Volunteers who participate in another study with an investigational drug within the last two months preceding the study
* Volunteers who are unable to refrain from smoking on study days
* Volunteers who smoke more than10 cigarettes (or equivalent) per day
* Volunteers who drink more than 60 g of alcohol per day
* Volunteers who are dependent on drugs
* Volunteers who donate blood (≥ 100 mL) within the last four weeks
* Volunteers who participate in excessive physical activities within the last week before the study (e.g. competitive sports)
* Volunteers who suffer from any other disease or abnormality of clinical relevance
* History of hemorrhagic diatheses
* History of gastro-intestinal ulcer, perforation or bleeding
* History of bronchial asthma
* History of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

Female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (IUD), oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
```

## Arms

- **Asasantin ER, new formulation I** (EXPERIMENTAL)
- **Asasantin ER, new formulation II** (EXPERIMENTAL)
- **Asasantin ER, present commercial formulation** (ACTIVE_COMPARATOR)

## Interventions

- **Asasantin ER, new formulation I** (DRUG)
- **Asasantin ER, new formulation II** (DRUG)
- **Asasantin ER, present commercial formulation** (DRUG)

## Primary Outcomes

- **Area under the concentration-time curve of dipyridamole in plasma at steady state (AUC,ss)** _(time frame: Up to 48 hours after start of drug administration)_
- **Percent peak trough fluctuation of dipyridamole in plasma (%PTF)** _(time frame: Up to 48 hours after start of drug administration)_

## Secondary Outcomes

- **Maximum concentration of the analytes in plasma at steady state (Cmax,ss)** _(time frame: Up to 48 hours after start of drug administration)_
- **Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)** _(time frame: Up to 48 hours after start of drug administration)_
- **Time from dosing to the maximum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ Time from dosing to the maximum measured concentration of the analytes in plasma at steady state (tmax,ss)** _(time frame: Up to 48 hours after start of drug administration)_
- **Percent area under the curve fluctuation of the analytes in plasma (AUCfluct)** _(time frame: Up to 48 hours after start of drug administration)_
- **Terminal half-life of the analytes in plasma (t1/2)** _(time frame: Up to 48 hours after start of drug administration)_
- **Percent of dose of the analytes recovered unchanged in urine (Ae%)** _(time frame: Up to 24 hours after start of drug administration)_
- **Ratio of peak concentration of the analytes in plasma over area under the curve at steady state (Cmax,ss / AUC,ss)** _(time frame: Up to 48 hours after start of drug administration)_
- **Number of subjects with clinically relevant changes in vital signs (blood pressure, pulse rate)** _(time frame: up to 8 days after last study drug administration)_
- **Number of subjects with clinically relevant changes in 12-lead ECG** _(time frame: up to 8 days after last study drug administration)_
- **Number of subjects with clinically relevant changes in laboratory values** _(time frame: up to 8 days after last study drug administration)_
- **Number of subjects with adverse events** _(time frame: up to 8 days after last study drug administration)_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02273518.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02273518*  
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