Study to Assess the Bioavailability of Ticagrelor OD Tabl... | NCT02400333

NCT02400333

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatments A-D-B-C sequence	Experimental	Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Treatments B-A-C-D sequence	Experimental	Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Treatments C-B-D-A sequence	Experimental	Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Drug: Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube Drug: Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water
Treatments D-C-A-B sequence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water	Drug	90 mg single dose	Treatments A-D-B-C sequence Treatments B-A-C-D sequence

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.	Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).	0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.	Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).	0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.
Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).	Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).	0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

Secondary Outcomes

Measure	Description	Time Frame
Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.	Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).	0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture. - Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range or Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation. - Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive. -Able to understand, read and speak the German language.

Exclusion Criteria: - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influence the results or the potential subject's ability to participate in the study.

Any abnormalities in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), urea, creatinine, thyroid-stimulating hormone (TSH), International Normalised Ratio (INR), activated partial thromboplastin time (aPTT), white blood cell (WBC) count, haemoglobin (Hb) or platelet count. Any other abnormal haematology, clinical chemistry, coagulation or urinalysis results, as judged with an unacceptable deviation that is considered to be clinically significant by the investigator.
Any clinically significant abnormal findings in vital signs, as judged by the investigator. at screening and at baseline (Day -1 of Treatment period 1), defined as:
- Systolic blood pressure < 90mmHg or ≥ 140 mmHg
- Diastolic blood pressure < 50mmHg or ≥ 90 mmHg
- Pulse < 50 or > 85 beats per minute (bpm)
Current smokers or those who have smoked or used nicotine products within the previous 3 months.
History of haemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
A personal history of vascular abnormalities including aneurysms; a personal history of severe haemorrhage, hematemesis, melena, haemoptysis, severe epistaxis, severe thrombocytopenia, intracranial haemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the investigator.
History of a clinically significant non-traumatic bleed or clinically significant bleeding risk, as judged by the investigator.
Use of aspirin, ibuprofen, non-steroidal anti-inflammatory drugs (NSAIDs), or any other drug known to increase the propensity for bleeding for 2 weeks before randomisation.
Platelet count less than 150 x 109/L.

Criteria applicable to insertion of a nasogastric tube:

History of severe midface trauma and/or recent nasal surgery.
History of coagulation abnormality, oesophageal varices or stricture, recent banding or cautery of oesophageal varices, and/or alkaline ingestion, at the discretion of the investigator.

Contacts/Locations Module

Name	Affiliation	Role
Rainard Fuhr, Dr. med.	PAREXEL International GmbH, Berlin	Principal Investigator

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ADBC Sequence	Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
FG001	BACD Sequence	Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Treatments C-B-D-A sequence

Treatments D-C-A-B sequence

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	ADBC Sequence	Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
BG001	BACD Sequence	Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
BG002	CBDA Sequence	Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
BG003	DCAB Sequence	Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG0019 BG0029 BG0039 BG00436

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Ticagrelor

Title	Measurements
	OG000428± 25.0 OG001499± 34.0 OG002479± 32.1 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.					Geometric mean ratio	84.85			2-Sided	90	76.77	93.78				No	Superiority or Other
OG001 OG003	Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.

Primary

Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.

The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.

Posted

Geometric Mean

Geometric Coefficient of Variation

h·ng/mL

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C

Primary

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).

Posted

Geometric Mean

Geometric Coefficient of Variation

h·ng/mL

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C

Secondary

Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.

Posted

Median

Full Range

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C

Secondary

Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.

Posted

Mean

Standard Deviation

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C

Secondary

Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.

Assesssment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002

Secondary

Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.

Assesssment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.

Secondary

Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.

Assesssment of MRAUC [0-∞] (Ratio of metabolite AUC [0-∞] to parent AUC [0-∞], adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.

Posted

Geometric Mean

Geometric Coefficient of Variation

ratio

0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.

Secondary

Percentage of Participants With Adverse Events (AEs).

An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.

The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.

Posted

Number

percentage of participants

SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B

Secondary

Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).

The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.

The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.

Posted

Mean

Standard Deviation

mmHg

Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C	Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
OG003

Secondary

Mean Change From Baseline for Vital Signs in Supine Pulse Rate.

Vital signs were collected after the participant has rested in the supine position for at least 5 minutes.

The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.

Posted

Mean

Standard Deviation

bpm

Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C	Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
OG003	Treatment D

Secondary

Participants With Significant Findings in 12-Lead Electrocardiography (ECG).

A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.

The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.

Posted

Number

participants

At screening and at follow-up.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002	Treatment C	Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).

Secondary

Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.

Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).

The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.

Posted

Number

participants

At screening, at admission on Day -1 to each treatment period and at follow-up.

ID	Title	Description
OG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
OG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
OG002

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment A	Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.	31	3	31
EG001	Treatment B	Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.	32	5	32
EG002	Treatment C	Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).	34	3	34
EG003	Treatment D	Participants received Ticagrelor IR tablets administered orally with 200 mL of water.	33	2	33

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk EG0030 affected33 at risk
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk EG003
Chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk EG003
Fatigue	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk EG003
Haematoma	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk EG003

ID	Term
D014867	Water
D005079	Excipients
D000077486	Ticagrelor

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477	Ions
D004573	Electrolytes
D010087	Oxides
D017601	Oxygen Compounds
D014677	Pharmaceutical Vehicles
D010592	Pharmaceutic Aids
D004364	Pharmaceutical Preparations
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).

Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.